Roche cobas Synergy Software Operators Manual

cobas Synergy software

For use with

cobas

®

6800/8800 Systems (software version 1.2.13) and

Microlab

®

STAR IVD

User Assistance Version 3.0

Software version 1.2

2

Publication information

Publication version

1.0

1.1

2.0

3.0

y Revision history

1.1

1.2

Software version

1.0

1.0

Revision date

December 2015

May 2016

December 2016

August 2017

Change description

First version o

New reports added in Operation part o

Retesting of invalid pools added o

Information added and updated for samples with high B19 titer o

Table added for minimum pool size o

Screenshots and texts updated in Configuration part o

Information about Aurora reports deleted u

What is new in publication version 1.1 (14)

u


u


Edition notice

Where to find information

This publication is intended for operators of the

cobas Synergy

software for use with

cobas

®

6800/8800

Systems (software version 1.2.13) and Microlab

®

STAR

IVD.

Every effort has been made to ensure that all the information contained in this publication is correct at the time of publishing. However, the manufacturer of this product may need to update the publication information as output of product surveillance activities, leading to a new version of this publication.

The

User Assistance

contains all information about the product, including the following:

• Routine operation

• Maintenance

• Safety

• Troubleshooting information

• A software reference

• Configuration information

• Background information

The

Safety Guide

contains important safety information.

You must read the Safety Guide before operating the

Microlab

®

STAR IVD.

The

User Guide

focuses on routine operation and maintenance. The chapters are organized according to the normal operation workflow.

For information about the

cobas

®

6800/8800 Systems, refer to the respective User Assistance.

Roche Diagnostics cobas Synergy software · Software version 1.2 · User Assistance · Version 3.0

Training

Disclaimer

Screenshots

Warranty

Copyright

For test-specific information, refer to the

Instructions for

Use

of the respective tests.

For information about the optional pre-analytical systems, refer to the respective user documentation.

!

General attention

To avoid serious or fatal injury and to avoid incorrect results, ensure that you are familiar with the system, the instructions, and safety information before you use the system.

r

Pay particular attention to all safety precautions and safety notices.

r

Always follow the instructions in this publication.

r Do not use the Microlab

®

STAR IVD in a way that is not described in this publication.

r Do not use the software in a way that is not described in this publication.

r Store all publications in a safe and easily retrievable place.

Do not carry out operation tasks or maintenance actions unless you have received training from Roche

Diagnostics. Leave tasks that are not described in the user documentation to trained Roche Service representatives.

Not every software version applies to all markets. Some content in this publication is related to products, configurations, or tests which are not available in all markets.

The screenshots in this publication have been added exclusively for illustration purposes. Configurable and variable data, such as tests, results, or path names visible therein must not be used for laboratory purposes.

Any customer modification to the system renders the warranty or service agreement null and void.

For conditions of warranty, contact your local sales representative or refer to your warranty contract partner.

Always leave software updates to a Roche Service representative, or perform such updates with their assistance.

© 2015–2017, F. Hoffmann-La Roche Ltd. All rights reserved.

3


4

License information

Open Source and Commercial Software

Trademarks

Feedback

Approvals

cobas Synergy

software is protected by contract law, copyright law, and international treaties.

cobas Synergy

software contains a user license between F. Hoffmann-La

Roche Ltd. and a license holder, and only authorized users may access the software and use it. Unauthorized use and distribution may result in civil and criminal penalties.

cobas Synergy

software may include components or modules of commercial or open source software. For further information on the intellectual property and other warnings, as well as licenses pertaining to the software programs included in

cobas Synergy

software, refer to the electronic distribution included with this product.

This open source and commercial software and

cobas Synergy

software as a whole can constitute a device regulated in accordance with applicable law. For more detailed information, refer to the user manual and labeling.

Please note that the respective authorization is no longer valid according to the corresponding legislation should any unauthorized changes be made to

cobas Synergy

software.

The following trademarks are acknowledged:

Microlab is a registered trademark of Hamilton Bonaduz

AG.

COBAS, COBAS P, COBAS SYNERGY, and LIFE NEEDS

ANSWERS are trademarks of Roche.

All other trademarks are the property of their respective owners.

Every effort has been made to ensure that this publication fulfills the intended use. All feedback on any aspect of this publication is welcome and is considered during updates. Contact your Roche representative, should you have any such feedback.

The Microlab

®

STAR IVD meets the requirements laid down in:

Directive 98/79/EC of the European Parliament and of the

Council of 27 October 1998 on in vitro diagnostic medical devices.


Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment.

Compliance with the applicable directive(s) is provided by means of the Declaration of Conformity.

The following marks demonstrate compliance:

For

in vitro

diagnostic use.

Complies with the provisions of the applicable EU directives.

C US

Issued by CSA Group for Canada and the US.

'Laboratory Equipment' is the product identifier as shown on the type plate.

5


6

Contact addresses

For

cobas Synergy

software:

Stratec Biomedical UK Limited

Centrum Point

Third Avenue

Centrum 100

Burton upon Trent

DE14 2WD

United Kingdom

For Microlab

®

STAR IVD:

HAMILTON Bonaduz AG

Via Crusch 8

CH-7402 Bonaduz

Switzerland

Made in Switzerland

Distributed in the EU by:

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Distributed in the US by:

Roche Diagnostics

9115 Hague Road

Indianapolis, Indiana

USA


Table of contents

7

Table of contents

Publication information

Contact addresses

Table of contents

Intended use

Symbols and abbreviations

What is new in publication version 3.0



Safety

1 General safety information

Introduction 19

Safety classifications

Safety precautions

Warning messages

Caution messages

20

21

24

28

Notices 33

Safety labels on the instrument

Safety information for lasers

Safety information for disposal

36

38

39

Description of cobas Synergy solution

2 Overview of cobas Synergy solution

About the

cobas Synergy

solution 45

3 Overview of the hardware

Pooling instrument overview 53

Consumables 70

External PC 74

4 Overview of cobas Synergy software

About the data manager

About the pooling instrument manager

About user management

About the User Assistance

5 Description of the pooling process

Overview of pooling process

Primary pools

Secondary pools

Individual donor testing (IDT)

99

100

101

104

Aliquots 105

Exclusion lists 106

6 Specifications

List of pooling instrument specifications

77

88

92

93

109

9

11

12

14

7

9

2

6

System operation

7 Workflow overview

Workflow for PP24 and PP96 pooling runs

Workflow for PP6 pooling runs

Workflow for aliquot runs

8 Before operation

Starting up and logging on

115

116

117

121

9 Operation

Basic operational tasks

Pooling operations

Reporting in the data manager

10 After operation

Shutting down the system

127

134

174

183

11 Maintenance

Maintenance intervals

Periodic maintenance

189

190

Regular maintenance 201

Decontamination 202

12 Quick references

Creating a pool

Preparing aliquot plates

Evaluating pool results

Daily maintenance on the pooling

208

209

210

instrument 212

Weekly maintenance on the pooling instrument 213

Troubleshooting

13 Troubleshooting

Troubleshooting on the Microlab

®

STAR

IVD 219

Troubleshooting on the data manager

List of data manager messages

233

236

Configuration

14 Configuration of pooling instrument manager

Managing users on the pooling instrument manager 249


8 Table of contents

15 Basic configuration of data manager

About basic configuration

Configuring targets

Configuring tests

Configuring primary runs

Assigning tests to IDT runs

Connecting instruments

Additional general settings

Processing results automatically

Backing up databases

Archiving databases

16 The Configuration environment

The Configuration environment of the data manager 285

Configuring LIS export

Creating messages

288

294

257

260

263

266

268

270

273

275

276

279

17 The Manager environment

The Manager environment of the data manager 301

Setting system information codes

Managing software access

Locking tests, reports, and accept methods 324

Entering laboratory details

Viewing log files

304

312

328

329

Appendix

18 Key terms

Comparison of key terms 335

19 Glossary

Index 339


Intended use

cobas Synergy

software manages samples to be processed on pre-analytic instruments as a front-end to the

cobas

®

6800/8800 Systems. The

cobas Synergy

solution collects data from pooling and analyzer instruments which allows the user to review results against individual samples and samples which have been pooled, creating output files from the data that can be sent to a laboratory information system.

cobas Synergy

software is intended for use by blood establishment personnel who are trained in its operation and are familiar with the associated tests and instruments.

Symbols and abbreviations

Product names

Symbols used in the publication

Except where the context clearly indicated otherwise, the following product names and descriptors are used.

Product name cobas Synergy

solution

cobas Synergy

core

cobas Synergy

software

Microlab

®

STAR IVD

cobas

®

6800/8800 Systems y

Product names

Descriptor

solution core software pooling instrument analytic system o

Symbol Explanation

List item

Search. Used on the search tab.

Table of contents. Used on the table of contents tab.

History. Used on the history tab to show previously viewed topics.

Favorites. Used on the favorites tab and on the content panel.

Enlarge. Button used on images.

Settings. Button used to open the settings dialog.

Contact. Used in the User Assistance.

Functionality currently unavailable.

y

Symbols used in the publication


9

10

Symbols used on product

Symbol Explanation

Global Trade Item Number.

Quantity contained in the package.

Abbreviations

DIS

CSA

EC

EN

IEC

LIS n/a

QC

QS

SD

TADM y

Symbols used on product

The following abbreviations are used.

Abbreviation

AD

ANSI

ASTM

IDT

IU

IVD

LIMS

UL

UPS

WEEE

Definition

Amplification and detection

American National Standards

Institute

American Society for Testing And

Materials

Donor information system

Canadian Standards Association

European Community

European standard

International Electrical

Commission

Individual donor testing

International unit

In vitro diagnostic

Laboratory information management system (another name for laboratory information system)

Laboratory information system not applicable

Quality control

Quantitation standard

Standard deviation

Total Aspiration Dispensing

Monitoring

Underwriters Laboratories Inc.

Uninterruptible power supply

Waste Electrical and Electronic

Equipment y

Abbreviations


What is new in publication version 3.0

Analytic system

Intended use

Pool details

Resending test results

Workflows in case of high B19 titer

Error messages

Configuring targets

Configuring tests

Screenshots updated

The

cobas Synergy

software version 1.2 can be used together with

cobas

®

6800/8800 Systems software version 1.2.13.

The intended-use section was updated.

u

Intended use (9)

The table was updated to match the information shown in the different panels of the software.

u

List of pool details (147)

The software now allows the resending of already d result on the

Results for review

panel. The procedure for reviewing results was updated accordingly.

u

Evaluating results for review (157)

The section was adapted to match the software version of the analytic system.

u

Handling invalid HAV results due to samples with high

B19 titer (171)

Additional messages were included.

u

List of data manager messages (236)

The software now allows to map the result terms per target. The description of configuring targets was updated accordingly.

u

Configuring targets (260)

The software now allows to configure a sample type per test, a volume per test, and to map the result terms per test. The description of configuring tests was updated accordingly.

u

Configuring tests (263)

Screenshots that are different with the new software version were replaced.

11


12


Analytic system

Sorting and filtering of tables

User management

Exclusion lists

Pooling and aliquot workflows

Quick references

Masking a test order

Searching samples


New cobas Synergy reports

Handling sample barcode errors

The

cobas Synergy

software version 1.1 can be used together with

cobas

®

6800/8800 Systems software versions 1.1.09, 1.1.10, or 1.2.12.

A new section about sorting and filtering of tables has been added.

u

Sorting and filtering data in tables (86)

New sections about the user management have been added.

u

About user management (92)

u

Managing users on the data manager (322)

A new section explaining the exclusion lists has been added.

u

Exclusion lists (106)

A new chapter with a summary about the pooling and aliquot workflows has been added.

A new chapter with quick reference information has been added.

The section about masking a test order has been updated and expanded.

u

About masking a test order (154)

A new section about searching samples has been added.

u

Searching samples (173)

The section was moved to the Operation chapter. The description was extended to differentiate between different software versions of the analytic system.

Information about the new

cobas Synergy

reports has been added.

• Where is my sample report

• Testing summary report

• Invalid test results report

• Pooler performance report

• Pooler performance export report u

cobas Synergy reports (175)

A new section about the handling of sample barcode reading errors has been added.

u

Sample barcode reading error (220)


Data manager messages

Backing up and archiving databases

User Assistance

General improvements

A list of data manager messages has been added. The list includes possible causes and recommended actions.

u

List of data manager messages (236)

The sections about backing up and archiving databases have been updated.

Archiving can be performed online now.

u

Backing up databases (276)

u

Archiving databases (279)

New context links for the

Administration

tab have been added to the User Assistance of the data manager.

u

About basic configuration (257)

General improvements have been made throughout this publication.

13


14


cobas Synergy reports added

Repeat testing on the analytic system


Minimum pool size

Updates in Configuration part

Aurora reports

In the Operation part, new

cobas Synergy

reports were integrated in the procedures. All reporting options in the data manager were summarized in one new section.

Descriptions of reporting in other places were shortened and instead referenced to the new section. u

Reporting in the data manager (174)

Information was added about repeat testing on the analytic system in case of invalid results.

u

Repeat testing on the analytic system after an invalid test result (169)

The section describing workflows in case of samples with high B19 titer was updated and extended.

An overview table for the minimum pool size was added.

u

Additional general settings (273)

Screenshots and texts in the Configuration part were updated to reflect changes in the user interface.

u

The Configuration environment (283)

u

The Manager environment (299)

The chapter describing Aurora reports was deleted

(legacy functionality only). Recommendation not to use

Aurora reports was added.

u



Safety

1 General safety information.................................................................................. 17


General safety information

Table of contents

17

1

In this chapter

1

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

19

Safety classifications . . . . . . . . . . . . . . . . . . . . . . . . . . .

20

Safety precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

21

Operator qualification . . . . . . . . . . . . . . . . . . . . . . .

21

Safe and proper use of the instrument . . . . . . . . .

21

Miscellaneous safety precautions . . . . . . . . . . . . .

23

Warning messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

24

Electrical safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

24

Optical safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

24

Biohazardous materials . . . . . . . . . . . . . . . . . . . . . .

25

Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

26

Explosion and fire . . . . . . . . . . . . . . . . . . . . . . . . . . .

27

Caution messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

28

Mechanical safety. . . . . . . . . . . . . . . . . . . . . . . . . . .

28

Proper identification . . . . . . . . . . . . . . . . . . . . . . . . .

29

Contamination. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

29

Collection media and other working solutions . . .

30

Fatigue due to long hours of operation . . . . . . . . .

31

Electromagnetic interference . . . . . . . . . . . . . . . . .

31

IT security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

32

Notices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

33

Moving parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

33

Circuit breakers and fuses . . . . . . . . . . . . . . . . . . .

33

Pipetting channels . . . . . . . . . . . . . . . . . . . . . . . . . .

34

Proper loading and handling . . . . . . . . . . . . . . . . .

34

Spillage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

35

Safety labels on the instrument . . . . . . . . . . . . . . . . . .

36

List of safety labels on the instrument. . . . . . . . . .

36

Location of safety labels on the instrument . . . . .

37

Safety information for lasers . . . . . . . . . . . . . . . . . . . . .

38

Safety information for disposal . . . . . . . . . . . . . . . . . . .

39

Disposal information . . . . . . . . . . . . . . . . . . . . . . . .

39


18

Table of contents


Introduction


19

!

General attention

To avoid serious or fatal injury, read this publication thoroughly before you use the instrument.

r

Pay particular attention to all safety precautions.

r Always follow the instructions in this publication. r

Do not use the instrument in a way that is not described in this publication.

r

Keep this publication in a safe place to ensure that it is not damaged and remains available for use.

This publication must always be easily accessible.


20 Safety classifications

Safety classifications

The safety precautions and important user notes are classified according to the ANSI Z535.6-2011 standard.

Familiarize yourself with the following meanings and icons:

!

Safety alert

r

The safety alert symbol is used to alert you to potential physical injury hazards. Obey all safety messages that follow this symbol to avoid possible damage to the components of the

cobas Synergy

solution, injury, or death.

These symbols and signal words are used for specific hazards:

!

WARNING

Warning...

r

...indicates a hazardous situation which, if not avoided, could result in death or serious injury.

!

CAUTION

Caution...

r ...indicates a hazardous situation which, if not avoided, could result in minor or moderate injury.

NOTICE

Notice...

r

...indicates a hazardous situation that, if not avoided, may result in damage to the system.

Important information that is not safety relevant is indicated with the following icon: q

Tip

...

...indicates additional information on correct use or useful tips.



21

Safety precautions

!

To avoid serious or fatal injury, read and comply with the following safety precautions.

In this section

Operator qualification (21)

Safe and proper use of the instrument (21)

Miscellaneous safety precautions (23)

Operator qualification

Insufficient knowledge and skills

As an operator, ensure that you know the relevant safety precaution guidelines and standards and the information and procedures contained in these instructions.

r

Do not carry out operation and maintenance unless

Roche Diagnostics has trained you to do so.

r

Leave maintenance, installation, or service that is not described to trained Roche Service representatives. r

Carefully follow the procedures specified in the instructions for operation and maintenance.

r

Follow good laboratory practices, especially when you work with biohazardous material.

Safe and proper use of the instrument

Missing personal protective equipment

Working without personal protective equipment means danger to life or health.

r

Wear appropriate personal protective equipment, including, but not limited to, the following items: o Eye protection with side shields o Fluid-resistant lab coat o Approved lab gloves o Face shield if there is a chance of splashing or splattering r

Follow good laboratory practices and regularly change lab gloves to minimize the risk of infection and contamination (especially after contact with waste or sample material).


22 Safety precautions

Installation

Correct use

Operating conditions

Approved parts

Authorized access

Risk of personal injury or damage to the instrument.

r

Installation must be performed by trained Roche service representatives only.

r

Use the Microlab

®

STAR IVD only for pooling samples as described in the

cobas Synergy

core user documentation.

Operation outside of the specified ranges may lead to incorrect results or malfunction of the instrument.

r

During operation, the instrument must be shielded from sunlight and intense artificial light. r

Position the instrument in the laboratory in a way permitting personnel to access the front and sides of the instrument.

r

Maintenance (daily maintenance, weekly maintenance, and periodic verification performed by

Roche service representatives) is a mandatory part of the work routine.

r

Keep the user documentation in a safe place to ensure it is not damaged and remains available for use. The documentation must be easily accessible at all times.

Use of nonapproved parts or devices may result in malfunction of the instrument and may render the warranty null and void.

r

Only use parts and devices approved by Roche

Diagnostics.

r

Only certified technicians are authorized to perform mechanical maintenance on the instrument.

Unauthorized access to the components of the

cobas Synergy

solution can result in data loss, solution damage or solution unavailability.

r

Only authorized persons may access solution components.



23

Miscellaneous safety precautions

Power interruption

Electromagnetic fields

Relocation and transportation

A power failure or momentary drop in voltage may damage the instrument or lead to data loss. r

Perform regularly backups of measurement results. r

An uninterruptible power supply (UPS) is recommended.

Although the Microlab

®

STAR IVD conforms to European norms with regards to interference immunity, exposure to electromagnetic RF fields, or direct discharge of static electricity can negatively affect liquid level detection ability.

r

Keep the Microlab

®

STAR IVD away from equipment that emits electromagnetic RF fields in the laboratory.

r

Minimize static electricity in the immediate environment of the Microlab

®

STAR IVD.

Risk of personal injury or damage to the instrument.

r

Never lift a fully installed instrument to transport it from one place to another. It must be reinstalled in the new work location by an authorized Roche service representative.


24 Warning messages

Warning messages

!

List of warning messages

Failure to observe warning messages may result in death or serious injury.

r

Before operating the solution, read the warning messages carefully.

In this section

Electrical safety (24)

Optical safety (24)

Biohazardous materials (25)

Waste (26)

Explosion and fire (27)

Electrical safety

Electric shock

Removing the covers or panels of electronic equipment can cause electric shock due to high-voltage parts inside.

r

Do not attempt to work on any electronic equipment.

r Do not remove any cover or panel of the instrument.

r

Only Roche Service representatives may install, service, and repair the instrument.

u

Related topics

• Safety labels on the instrument (36)

Optical safety

Blindness due to intense barcode reader light

The intense light of a laser or LED barcode reader may severely damage your eyes or result in exposure to hazardous radiation.

r

Do not stare into the beam of a laser or LED barcode reader.

r

Do not remove the housing from barcode readers.

r Do not perform any maintenance actions on barcode readers. If you experience problems with the barcode readers, contact your Roche Service representative.

r

Perform only the procedures described in operating instructions. Performing unauthorized procedures may result in exposure to hazardous radiation.



25

Biohazardous materials

Infectious samples

Operator infection and injury

Contact with samples containing material of human origin may result in infection. All materials and mechanical components associated with samples containing material of human origin are potentially biohazardous.

r

Follow good laboratory practices, especially when working with biohazardous material.

r

Keep all covers closed while the instrument is operating. r

Wear appropriate personal protective equipment. r

If any biohazardous material is spilled, wipe it up immediately and apply a disinfectant.

r

If sample or waste comes into contact with your skin, wash the affected area immediately with soap and water and apply a disinfectant.

Consult a physician.

Contact with instrument mechanisms (for example, sample pipetter, reagent pipetter, main handler, transfer module handler, processing module handler, reagent cassette handler, etc.) or with the instrument chassis or covers may result in personal injury and infection. r

Whenever possible, keep the front cover of the instrument closed. r

Always ensure that the instrument is off or in

Maintenance

status, before you work with an opened cover (for example, for cleaning or maintenance).

r

Do not open the front cover while the instrument is performing maintenance. r

Be careful not to hit your head when the covers are open. r

Pay attention to the covers during automatic movement, check for obstructions and keep out of reach.

r

Do not touch any parts of the instrument other than those specified.

r

Never reach into the instrument while parts are moving.

r

Carefully observe all instructions given in this publication.


26 Warning messages

Waste

Infection by biohazardous material

Smoke due to electrical malfunction

Troubleshooting procedures

r

Do not eat, drink, or smoke in laboratory work areas.

r

Wear personal protective equipment whenever preparing consumables or when cleaning.

r

Change lab gloves frequently.

r

Wear eye protection when handling samples. Wash hands thoroughly afterwards.

Electrical malfunction can result in the emission of hazardous smoke. Inhaling smoke emitting from the instrument can lead to personal injury.

r

If you see smoke coming from the instrument: o

Avoid inhaling o

Disconnect from power supply o

Contact Roche Service immediately

Corrective measures in troubleshooting procedures can result in exposure to biohazardous materials.

r

Always follow the troubleshooting procedures given in software wizards and/or in the user documentation.

r

Wear appropriate personal protective equipment when implementing corrective measures.

Infectious waste

Contact with solid waste may result in infection. All materials and mechanical components associated with the solid waste unit are potentially biohazardous.

r

Wear appropriate personal protective equipment.

Take extra care when working with lab gloves. They can easily be pierced or cut, leading to infection.

r

If any biohazardous material is spilled, wipe it up immediately and apply a disinfectant.

r

If waste comes into contact with your skin, wash the affected area immediately with soap and water and apply a disinfectant.




27

Environmental harm

The instrument generates solid waste. Solid waste is potentially biohazardous. Improper disposal may contaminate the environment.

r

Treat solid waste as infectious waste.

r

Dispose of waste in accordance with the local regulations.

u

Related topics


• Safety information for disposal (39)

Explosion and fire

Fire risk through use of sprays

Spraying liquid on the power supply parts can cause a short circuit and result in a fire.

r

Keep the cover closed while the instrument is connected to the power supply and do not use sprays in the vicinity of the instrument.

r

Do not spray directly at the autoload unit or at electrical boards or connectors.

r

Do not clean the instrument in the vicinity of open flames or devices that can create sparks.

r

Do not use hot air blowers to dry the instrument. The liquids used for cleaning are flammable.


28 Caution messages

Caution messages

!

List of caution messages

r

Before operating, read the caution messages carefully.

Failure to observe them may result in minor or moderate injury.

In this section

Mechanical safety (28)

Proper identification (29)

Contamination (29)

Collection media and other working solutions (30)

Fatigue due to long hours of operation (31)

Electromagnetic interference (31)

IT security (32)

Mechanical safety

Moving parts

Contact with moving parts may result in personal injury.

r

Keep all covers closed and in place while the instrument is operating. An interlock system prevents operation of moving parts when the covers are open.

r Always ensure that the instrument is off or in

Maintenance

status, before you work with an opened cover (for example, for cleaning or maintenance).

r Do not touch any parts of the instrument except those parts specified. Keep away from moving parts during operation.

r

During operation and maintenance, carefully follow the instructions.

u

Related topics




29

Proper identification

Incorrect data caused by exchanging sample positions

Exchanging positions of sample tubes or switch aliquot plates after they have been identified by the barcode reader can result in incorrect test data or a hardware error.

r

Do not exchange positions of sample tubes or switch aliquot plates after they have been identified by the barcode reader.

Contamination

Contamination due to improper loading

Incorrect loading of the instrument can result in contamination.

r

Handle any one-track carrier (such as a sample carrier) with particular care, as this type of carrier can fall over and cause injury or contamination.

r

Make sure the carriers are inserted completely until they touch the stop hooks on the autoload tray.

r

Make sure there are no carriers loaded on the same tracks as already loaded carriers on deck.

r

Perform weekly maintenance if any parts of the instrument, carriers, or racks become contaminated.



Collection media and other working solutions

Skin inflammation or injury

Contaminated samples, foam, clots, films, or bubbles

Evaporation of samples

Incorrect results due to reuse of container caps

Direct contact with reagents, detergents, cleaning solutions, or other working solutions may cause skin irritation, inflammation, or burns.

r

When you handle reagents, exercise the precautions required for handling laboratory reagents. r

Wear appropriate personal protective equipment. r

Observe the instructions given in the Instructions for

Use for the test.

r

Observe the information given in Safety Data Sheets

(available for Roche Diagnostics reagents and cleaning solutions).

r

If reagents, detergents, or other cleaning solutions come into contact with your skin, wash the affected area immediately with soap and water and apply a disinfectant.


Incorrect results may occur due to insoluble contaminants, foam, fibrin clots, films, or bubbles in samples.

r

Ensure good sample preparation and handling techniques to avoid the formation of foam, clots, and bubbles in all samples.

r

Make sure that the samples contain no insoluble contaminants, such as fibrin or dust.

Evaporation of samples may lead to incorrect or invalid results.

r

Sample material may evaporate if left open. Do not leave samples open for any length of time.

r

For information about sample stability, see the applicable

Instructions for Use

.

Reuse of caps for containers and tubes can lead to contamination, resulting in an incorrect result.

r

Do not reuse caps.



31

Fatigue due to long hours of operation

Fatigue due to long hours of operation

Looking at the monitor over an extended time may lead to eye strain or body fatigue. r

Take a break to relax, in accordance with your laboratory's standard operating procedures or local regulations.

Electromagnetic interference

Electromagnetic interference

Strong electromagnetic fields (originating from unshielded radio frequency sources) can interfere with proper operation and may lead to malfunction of the instrument and incorrect results.

r

Do not use this instrument near sources of strong electromagnetic fields because these fields can interfere with the proper operation.

r

Evaluate the electromagnetic environment before you operate the instrument.

r

Take measures to mitigate the interference.



IT security

Data loss or unavailability of the solution due to malicious software or unauthorized access

Malicious software or unauthorized access can result in data loss or solution unavailability.

To avoid infection by malicious software or the unauthorized access and misuse of the solution, the following recommendations are essential: r

Do not install and/or execute any other software on the solution.

r

Make sure other computers and services on the network (for example, the LIS, archiving share, backup share, or service) are properly secured and protected against malicious software and unauthorized access.

r

Customers are responsible for the security of their local area network, especially in protecting it against malicious software and attacks. This protection might include measures, such as a firewall, to separate the device from uncontrolled networks as well as measures that ensure that the connected network is free of malicious code.

r

The Roche-provided firewall is mandatory and part of the solution.

r

Make sure that system backup and archive files are protected from any unauthorized access and disaster, this includes: remote storage location; disaster recovery sites; secure transfer of backup files.

r

Prevent credential theft.

o

Use strong passwords.

o

Do not share passwords.

o

Do not write passwords down.

o

Do not use the same credentials on multiple instruments.



33

Notices

!

List of notices

Failure to observe the notices may result in damage to the solution.

r

Before operating, read the notices contained in this summary carefully.

In this section

Moving parts (33)

Circuit breakers and fuses (33)

Pipetting channels (34)

Proper loading and handling (34)

Spillage (35)

Moving parts

Damage to the instrument due to contact with moving parts

Contact with moving parts may bend the pipette tips or damage some other component.

r

Keep all covers closed and in place while the instrument is operating.

r

Do not remove carriers from the Microlab

®

STAR IVD instrument until they have been transferred back to the autoload tray.

r Whenever it is necessary to move pipetting channels on the x-arm, move them gently by pushing close to their y-slide (carrier that allows pipetting channels to move away from and towards the operator). Never force them as this may lead to damage. If possible, switch on the instrument as this will result in a smoother motion when pipetting channels have to be moved on the x-arm.

Circuit breakers and fuses

Circuit breakers and fuses

Improper use may result in damage to the instrument.

r

If one of the circuit breakers or fuses blows, do not attempt to operate the instrument before contacting your Roche Service representative.


34 Notices

Pipetting channels

Damage to the instrument due to improper use

Leaving pipette tips on the pipetting channels for a long period of time may cause damage to the pipette tip

O-rings.

r

Do not leave pipette tips on the pipetting channels for a long period of time (for example, overnight). r

Remove the pipette tips with daily maintenance.

Proper loading and handling

Damage to the instrument due to improper loading

Interference due to incorrect handling

Incorrectly loading the instrument can result in damage r

Aliquot plates must be placed on the carrier so that well A1 is in the position defined in the user documentation.

r

5-position racks must be placed on the 5-position rack carrier so that the first rack is located immediately next to the carrier barcode label.

If the instrument is positioned on a table containing storage cabinets, attempting to access cabinets underneath the instrument during a run may interfere with automatic loading and unloading of carriers.

r

Do not access cabinets underneath the instrument during operation.


Spillage


35

Spilled liquid

Any liquid spilled on the instrument may result in malfunction or damage. r

Place samples, reagents, or any other liquid only at the intended positions.

Do not place samples, reagents, or any other liquid on the covers or other surfaces of the instrument.

r

When you remove or replace consumables, do not spill any liquid on the instrument.

r

If liquid does spill on the instrument, wipe it up immediately and follow the applicable decontamination procedure. Wear appropriate personal protective equipment.

Dispose of waste according to the local regulations.

u Decontamination procedures are described in the

Decontamination

section in the user documentation.


36 Safety labels on the instrument

Safety labels on the instrument

In this section

List of safety labels on the instrument (36)

Location of safety labels on the instrument (37)

List of safety labels on the instrument

Warning labels are placed on the instrument to draw your attention to areas of potential hazard. Listed below are labels and the definitions according to the location on the instrument.

The safety labels on the instrument comply with the following standards: ANSI Z535, IEC 61010-1, IEC 60417,

ISO 7000, or ISO 15223-1.

In addition to the safety labels on the instrument, there are safety notes in the corresponding parts of the user documentation.

q

Only Roche Service representatives are to replace damaged labels. For replacement labels, contact your local Roche Service representative.

Electrical

If you access a part of the instrument marked with this label, contact with electrical components may cause an electric shock.

Refer to the user documentation for instructions on safe operation.

General warning

Potential hazards located near this label may lead to death or serious injury.

Refer to the user documentation for instructions on safe operation.

Laser transmitter

There is a danger of contact with laser light or severe damage to the eyes.

Do not stare into the laser transmitter.

Biohazard

Potentially biohazardous materials are used near this label.

Observe relevant good laboratory practices on safe usage.



37

The safety messages give more detailed information about potentially hazardous situations that may arise during daily operation, or when carrying out maintenance actions.

When working with the instrument, observe both the safety labels on the instrument and the safety messages in the user documentation.

Location of safety labels on the instrument

w

Location of safety labels on the Microlab

®

STAR IVD


38 Safety information for lasers

Safety information for lasers

The instrument includes a barcode reader. The instrument is a class 2 laser product. Do not stare into the beam.

The mentioned classes refer to the standard IEC 60825-1:

• Class 1: Eye-safe under normal operating conditions.

• Class 2: Visible lasers. Eye-safe for accidental viewing.

It may not be safe to deliberately stare into the laser beam for longer than 0.25 s, overcoming the natural aversion response to the bright light.

Module

Barcode reader y

Lasers on the instrument

Wavelength

650–690 nm

Operating voltage

10–30 V(DC)

Max. output

1.3 mW

Remark

Class 2 laser



39

Safety information for disposal

Disposal information

Infection by a biohazardous instrument

r

Treat the instrument as biohazardous waste.

Decontamination (the combination of processes including cleaning, disinfection, and/or sterilization) is required before reuse, recycling, or disposal of the instrument.

r

Dispose of the instrument according to the local regulations. For more information, contact your Roche

Service representative.

Electronic equipment

Disposal of electronic equipment

This symbol appears on any component of the

cobas Synergy

solution that is covered by the European

Directive on Waste Electrical and Electronic Equipment

(WEEE).

You must dispose of these items through designated collection facilities appointed by government or local authorities.

Contact your city office, waste disposal service, or your

Roche Service representative for more information about disposal of your old product.

Constraint:

It is left to the responsible laboratory organization to determine whether electronic equipment components are contaminated or not. If contaminated, treat them in the same way as the instrument.


40 Safety information for disposal


Description of cobas Synergy solution

2 Overview of cobas Synergy solution ............................................................... 43

3 Overview of the hardware ................................................................................... 51

4 Overview of cobas Synergy software.............................................................. 75

5 Description of the pooling process ................................................................. 97

6 Specifications.........................................................................................................107


Table of contents

43

Overview of cobas Synergy solution

2

In this chapter

2

About the cobas Synergy solution . . . . . . . . . . . . . . . .

45

Components of the cobas Synergy solution . . . . .

46

Client-server architecture . . . . . . . . . . . . . . . . . . . .

48

Run types. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

49


44

Table of contents



45

About the cobas Synergy solution

The

cobas Synergy

solution combines pre-analytic sample handling (optional), sample pooling, and nucleic acid testing into one solution for blood screening laboratories.

The main features are:

• High-throughput solution.

• One data manager for handling orders and results.

• Communication between components for continuous sample tracking.


46 About the cobas Synergy solution

Components of the cobas Synergy solution

The

cobas Synergy

solution consists of the following components:

•

cobas Synergy

core:

-

cobas Synergy

software (data manager and pooling instrument manager)

- Microlab

®

STAR IVD

•

cobas

®

6800/8800 Systems

• Pre-analytical systems (optional)

cobas Synergy solution cobas Synergy core data manager

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(optional)


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Components of the

cobas Synergy

solution

Data manager

The data manager handles orders, results, and aliquot plate data:

• Pool orders and test orders:

Order confirmation, change requests, masking, recovering, and forcing results to the unresolved status

• Results:

Validating, transmitting, and rejecting

• Aliquot plate data:

Managing plate content data

It also manages the exclusion lists for seropositive and

WNV samples and generates reports.



47

Microlab

®

STAR IVD

The Microlab

®

STAR IVD (pooling instrument) performs the pooling runs and the aliquot runs. Each pooling instrument has a control unit with the pooling instrument manager.

Up to 24 pooling instruments can be connected to a

cobas Synergy

core.

Pooling instrument manager

The pooling instrument manager guides the user through the pooling runs and the aliquot runs. Pool sizes of 96, 24, and 6 are possible. All secondary pools have a size of 6.

After loading, the pooling instrument manager transmits the sample IDs to the data manager.

After the pooling run, the pooling instrument manager transmits the pool tube IDs and pool compositions to the data manager.

cobas

®

6800/8800 Systems

The

cobas

®

6800/8800 Systems perform the nucleic acid testing.

Up to 5 analytic systems can be connected to a

cobas Synergy

core.

Pre-analytical systems

The optional pre-analytical systems read the sample IDs, decap the sample tubes, and sort the samples, for example into 24- or 32-position sample carriers for the pooling instrument or into 5-position racks destined for the analytic system. After sorting, the sample IDs can be transmitted to the data manager.



Client-server architecture

The following overviews illustrate possible client-server architectures of the

cobas Synergy

solution:

LIS

Pre-analytical systems

ÀUHZDOO

(provided by Roche) pooling instrument manager control units

Microlab ® STAR IVD data manager workstations data manager server

cobas

®

6800/8800

Systems w

Client-server architecture of the

cobas Synergy

solution (without middleware)



49

LIS

Pre-analytical systems data manager workstations

Middleware

ÀUHZDOO

(provided by Roche) data manager server pooling instrument manager control units

Microlab ® STAR IVD

cobas

®

6800/8800

Systems w

Client-server architecture of the

cobas Synergy

solution (with middleware)

Run types

Pooling run

There are two run types: the pooling run and the aliquot run.

In the pooling run, pools are created on the pooling instrument and analyzed on the analytic system.



w Pooling run

Aliquot run

In the aliquot run, aliquot plates are prepared using the pooling instrument.

w

Aliquot run


Overview of the hardware

Table of contents

51

3

In this chapter

3

Pooling instrument overview. . . . . . . . . . . . . . . . . . . . .

53

About the covers on the pooling instrument . . . .

53

About the LED bar on the pooling instrument . . .

55

About the instrument deck . . . . . . . . . . . . . . . . . . .

56

About the autoload unit. . . . . . . . . . . . . . . . . . .

60

About the pipetting arm. . . . . . . . . . . . . . . . . . .

62

About the teaching needles . . . . . . . . . . . . . . .

62

About the solid waste station setup. . . . . . . . .

63

About the status light. . . . . . . . . . . . . . . . . . . . . . . .

65

About the carriers and racks . . . . . . . . . . . . . . . . .

65

Sample carriers . . . . . . . . . . . . . . . . . . . . . . . . . .

66

5-position racks . . . . . . . . . . . . . . . . . . . . . . . . .

67

Pool carrier . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

68

Aliquot plate carrier . . . . . . . . . . . . . . . . . . . . . .

69

Tip rack carrier . . . . . . . . . . . . . . . . . . . . . . . . . .

69

Consumables. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

70

Tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

70

Pipette tips. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

72

Aliquot plates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

73

External PC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

74


52

Table of contents



53

Pooling instrument overview

In this section

About the covers on the pooling instrument (53)

About the LED bar on the pooling instrument (55)

About the instrument deck (56)

About the status light (65)

About the carriers and racks (65)

About the covers on the pooling instrument

A

B

C

A

Left side cover

B

Front cover w

Covers of the pooling instrument

C

Right side cover

The front cover protects you from moving parts inside the pooling instrument. Open the front cover for user interaction during maintenance. Always close the front cover when you have finished maintenance work. During a run, the front cover must remain closed.


54 Pooling instrument overview

NOTICE

Loss of materials due to forced opening of front cover

The front cover is locked during a run. Forcing open the front cover during a run, causes an emergency stop. The run is aborted and all samples in processing are lost. r Do not attempt to start the run with the cover open.



55

About the LED bar on the pooling instrument

The LED bar above the autoload tray indicates the loading status on the instrument deck. The LEDs inform you where to place the carriers on the autoload tray and which tracks on the instrument deck have a carrier on them.

A B

A

Track

B

LED bar above the autoload tray indicating the loading status

LED status

No light

Green light steady

Green light blinking y Status LEDs on LED bar

Meaning

No carrier loaded.

Carrier loaded on this track.

Carrier required on this track.

User action

No action necessary.

No action necessary.

Place the carrier on the autoload tray on the indicated tracks. Insert the carrier until it touches the stop hook.



About the instrument deck

Instrument deck layout

The work area of the pooling instrument is called

instrument deck

. The instrument deck holds the removable carriers for:

• Samples

• Pool tubes

• Aliquot plates

• Pipette tips

The instrument deck is divided into 54 equal tracks. The tracks are numbered for identification of the location where carriers must be loaded. The track numbers are stamped on the surface of the autoload tray. A corresponding LED on the LED bar above the autoload tray indicates the loading status of each track.

The track assignment is different for pooling and aliquot runs.

A

A

Samples in 24- or 32-position sample carriers

B

Pool tubes in 5-position racks on pool carriers or in 32position carriers w Instrument deck layout for pooling runs

B

C

Tip rack carriers

C

The following table summarizes the track positions on the instrument deck for pooling runs.


Pooling runs

Carriers

32-position sample carriers:



57

Track

1-32

Used for

Sample tubes

Max. loading

768 sample tubes on 24 × 32-position sample carriers or on 32 × 24-position sample carriers

5-position racks on pool carriers:

32-position carriers:

Tip rack carriers: y

Track positions on instrument deck for pooling runs

33-40 Pool tubes 128 pool tubes

43-54 Pipette tips 960 pipette tips



A

A

Samples in 24- or 32-position sample carriers

B

Aliquot plates in aliquot plate carriers w

Instrument deck layout for aliquot runs

B

C

Tip rack carriers

C

The following table summarizes the track positions on the instrument deck for aliquot runs.


Aliquot runs

Carriers




59

Track

1-28

Used for

Sample tubes

Max. loading

672 sample tubes on 28× 24-position sample carriers or on 21× 32-position sample carriers

Aliquot plate carriers: 29-40 Aliquot plates 672 aliquots on 7 aliquot plates

43-54 Pipette tips 960 pipette tips Tip rack carriers: y

Track positions on instrument deck for aliquot runs

In this section

About the autoload unit (60)

About the pipetting arm (62)

About the teaching needles (62)

About the solid waste station setup (63)



About the autoload unit

The autoload unit consists of the autoload tray - the platform where the carriers are placed - and the autoloader. The autoloader detects waiting carriers with their tubes, aliquot plates, and tip racks and reads the barcode labels.

The autoload unit is used to load carriers automatically on the pooling instrument. The user inserts the carriers into their designated position on the autoload tray. A blinking

LED on the LED bar above the autoload tray indicates the correct loading position.

D

E

F

A

A

Inserted carrier waiting to be loaded

B

Slide block

C

Track number stamped on the autoload tray w

Autoload unit with autoload tray and autoloader

B C

D

Autoloader with barcode reader

E

Stop hook

F

Autoload tray

After correct placement, the carriers are loaded automatically on the instrument deck by the autoloader.

During loading, the barcode reader on the autoloader reads the carrier barcode label and the barcode labels of the supplies on the carrier (sample tubes, pool tubes, aliquot plates, and tip racks).



61

Inserting carriers on autoload tray

The autoload tray contains slide blocks that engage tracks in the carriers to guide the carriers when they are loaded. Insert the carriers into the tracks between the front and rear slide blocks of the autoload tray. When inserting a carrier onto the autoload tray, be sure that the tracks on the carrier properly engage with the slide blocks.

Insert the carriers into their designated position on the autoload tray until they touch the stop hooks on the far side of the autoload tray.

NOTICE

Pooling instrument damage due to improper carrier handling

r

Make sure that the carriers are inserted completely until they touch the stop hooks on the autoload tray.

Exercise care when inserting the carriers - do not push carriers against the stop hooks with excessive force to prevent hardware damage.

Use special care when placing carriers on tracks with a broken stop hook.

u

Loading and unloading carriers (127)

u

Placing carriers when a stop hook is broken (232)

Safety guards

The autoload tray has safety guards attached on each side. Extend the safety guards to avoid bumping into the carriers on the autoload tray.

!

CAUTION

Personal injury due to bumping into carriers on autoload tray

r

Keep safety guards on both sides of the autoload tray extended to avoid bumping into carriers on the autoload tray.

!

WARNING

Erroneous result due to bumping into sample carrier on autoload tray (resulting in contamination).

r Keep safety guards on both sides of the autoload tray extended to avoid bumping into carriers on the autoload tray.

u

Related topics

• About the LED bar on the pooling instrument (55)



About the pipetting arm

A

B

A

Pipetting channel

A

About the teaching needles

C

The pooling instrument is equipped with a pipetting arm containing eight pipetting channels. Each airdisplacement pipetting channel can move forward and backwards and up and down during pipetting.

At the beginning of a pipetting cycle, the pipetting arm moves horizontally, picks up the required number of disposable pipette tips, and then aspirates, dispenses, and mixes the liquids. After that, the pipetting arm ejects the used pipette tips into the solid waste bag.

The teaching needles are stored near the solid waste station. They are used during daily and weekly maintenance for checking the tightness of the pipetting channels. Cleaning of the teaching needles is done as part of the preventive maintenance by your Roche Service representative.



63

About the solid waste station setup

Solid waste: pooling instrument on a bench top

How you manage your solid waste depends on your type of solid waste station setup.

The pooling instrument can be installed on one of the following bases:

• Bench top

• Trolley (accommodates a larger solid waste bag)

If the pooling instrument is installed on a bench top, a small solid waste bag is used. The solid waste bags hold the used pipette tips after they have been ejected.

A

B

A

Support frame

B

Small solid waste bag

!

WARNING

Erroneous result due to contamination caused by overflowing of solid waste

Avoid overfilling of the solid waste.

r Replace the small solid waste bag when it is full.

u

To empty tip waste and clean the tip eject plate p (194)

u

To empty tip waste p

(197)



Solid waste: pooling instrument on a trolley

If the pooling instrument is installed on a trolley, a plastic waste chute can be used in place of the solid waste bag.

The tip waste is directed into a solid waste container that holds a large solid waste bag and is located on the trolley.

A

B

C

D

A

Waste chute

B

Trolley

Solid waste container

C

Large solid waste bag

D

Solid waste container

The waste chute and solid waste container cannot be reused and must be replaced when they are full.

The waste chute is replaced in the same way as the solid waste bag.

Dispose of waste in accordance with the local regulations.

When you replace the solid waste container, also replace the waste chute.

u

To empty tip waste and clean the tip eject plate p (194)

u

To empty tip waste p

(197)



65

u

Related topics

• Performing daily maintenance (191)

• Performing weekly maintenance (195)

About the status light

A

The status light on top of the pooling instrument informs the user of the status of the pooling run:

• green = pooling run completed

• red = pooling run aborted u

Related topics

• Creating a pool (136)

A

Status light

About the carriers and racks

Carrier for

Sample tubes

Pool tubes

Aliquot plates

Pipette tips y

Carriers used in the system

Carrier

24-position sample carrier


Pool carrier

32-position carrier

Aliquot plate carrier

Tip rack carrier

The following carriers are used:

Used for

Samples

Samples

Pool tubes in 5-position racks

Pool tubes

Aliquot plates

Tip racks

In this section

Sample carriers (66)

5-position racks (67)

Pool carrier (68)

Aliquot plate carrier (69)

Tip rack carrier (69)



Sample carriers

Samples are placed in 24-position or 32-position sample carriers.

The sample barcode labels must face to the right of the carrier.

!

WARNING

Erroneous result due to use of inappropriate or closed tubes

Using the incorrect tubes or closed tubes on sample carriers can damage the pooling instrument. r

Use only specified tubes for sample carriers.

r Do not use closed tubes on sample carriers. Always open tubes on all sample carriers.

24-position and 32-position sample carriers

A

A

Sample tubes

B

Carrier barcode

B A B

Sample tubes are placed in 24-position and 32-position sample carriers. Each carrier type uses one track on the instrument deck.

• 24-position carriers hold tubes with a diameter of

16 mm.

• 32-position carriers hold tubes with a diameter of

13 mm.

q

Open the sample tubes before inserting the carrier on the autoload tray.

The 32-position carriers can also be used for pool tubes.

!

CAUTION

Infection by samples and associated materials

Single track carriers (such as a sample carrier) can fall over and cause injury or contamination.

r

Handle single track carriers with particular care when positioning them on the autoload tray.



67

5-position racks

The 5-position racks hold up to five pool tubes.

Each 5-position rack must have a unique barcode ID.

5-position racks are placed on 5-position rack carriers

(pool carriers) or directly on the analytic system for individual donor testing (IDT).

5-position rack without stabilizers

This rack has no stabilizers. There are dedicated racks for

13-mm and 16-mm tubes. Pool tubes have a diameter of

13 mm. Therefore, use only 13-mm racks for pool tubes.

The barcode labels of tubes must face to the right, so they can be read during loading.

5-position rack with stabilizers

You can also use 5-position racks with stabilizers for pool tubes.

The barcode labels of tubes must face to the right, so they can be read during loading. The 5-position racks with stabilizers prevent tube rotation during loading and therefore minimize barcode reading errors.



Pool carrier

A

First position

A

Pool tubes are placed either in 5-position racks, which are placed on pool carriers (

pool carriers

are 5-position rack carriers) or directly in 32-position carriers.

The barcode labels on the pool tubes must face to the right of the carrier.

!

WARNING

Erroneous result due to use of inappropriate or closed tubes

Using the incorrect tube types or closed tubes on pool carriers can damage the pooling instrument. r Use only specified tube types for pool carriers.

r

Do not use closed tubes on pool carriers. Always open tubes on all pool carriers.

r

Always load the first position of the pool carrier.

Up to four 5-position racks can be loaded onto a pool carrier. A pool carrier uses one track on the instrument deck.

Always use empty pool tubes.

!

CAUTION

Infection by samples and associated materials

Single track carriers (such as a pool carrier) can fall over and cause injury or contamination.

r

Handle single track carriers with particular care when positioning them on the autoload tray.



69

Aliquot plate carrier

A B C

A

Aliquot plate

B

Barcode label of an aliquot plate facing to the right

C

First position on aliquot plate carrier

The aliquot plate carrier holds up to five aliquot plates.

Place the aliquot plate carrier on the autoload tray for loading. Up to two aliquot plate carriers can be loaded for one run.

The barcode label of the aliquot plates must face to the right side of the carrier when they are loaded into the carrier. The aliquot plate barcode is read during loading of the carrier.

Only load the required number of aliquot plates as indicated in the software. Do not load additional plates that are not needed in the run.

Always use empty aliquot plates.

Aliquot plate carriers that are loaded with filled aliquot plates must be handled with care to avoid spillage of liquid.

Tip rack carrier

A

Tip rack

B

Tip rack carrier

A B

The tip rack carrier holds the tip racks with the disposable pipette tips.

The tip rack barcode labels must face to the right of the carrier.

q o

The total number of pipette tips per run varies and depends on several criteria.

o

The pooling instrument checks if enough pipette tips have been loaded to perform the run. If there are not enough, a message is displayed. To avoid this message, fully load all the required tip rack carriers for each run.

o

Partially used tip racks can be used in the next run. u

Related topics

• Preparing a tip rack carrier (132)


70 Consumables

Consumables

Consumables are disposable items used during processing. Consumables must be replaced and disposed of according to the applicable regulations.

!

WARNING

Damage and incorrect results due to use of unsuitable consumables

Use of non-Roche consumables may damage the pooling instrument or lead to incorrect results.

r Use only Roche consumables designed for use on the system.

r Do not reuse consumables. All consumables are designed for one time use only.

r Inspect consumables before use. Do not use damaged consumables. Do not reuse consumables from another system.

r

Do not use reagents and consumables that have exceeded their expiry dates. Replace expired consumables with unexpired consumables before processing.

Tubes

Tubes are used for samples and for pools.

Sample tubes

Carrier type



Sample tubes

13 × 75 mm

16 × 100 mm y

Sample tube dead volumes for a PP6 workflow

Sample tubes are standard, decapped blood collection tubes, with a diameter of 13-16 mm and a height of

75-100 mm.

Roche recommends using 13-mm tubes as sample tubes because of the lower dead volume.

The following dead volumes have been measured for a

PP6 workflow:

Sample volume

600 μ L

700 μ L

Dead volume

200 μ L

300 μ L

The following dead volumes have been measured for an aliquot workflow:



71

Carrier type



Sample tubes

13 × 75 mm

16 × 75 mm y

Sample tube dead volumes for an aliquot workflow

Dimensions and position of barcode labels on sample tubes

C B C

E

F

D

100 2489

A

Pool tubes

Sample volume

1250 μ L

1350 μ L

Dead volume

250 μ L

350 μ L

The dimensions of the barcode labels on sample tubes must be as follows:

A

Label length: max. 80 mm

B

Code length: max. 74 mm

C

Quiet zone: min. 3 mm

D

Label width: min. 12 mm

E

Code width: min. 12 mm

F

Distance from code to label edge: max. 1 mm y

Barcode label dimensions on sample tubes

The barcode label must fit within a specific range on the sample tube.

The following table lists the minimum and the maximum distances from the tube bottom.

Sample tube and pool tube

y

Position ranges for barcode labels

A

(min.)

20 mm

The bars must be perpendicular to the tube.

B

(max.)

100 mm

Use only

cobas omni

tubes (13 x 75 mm) as pool tubes.

They are available as consumables.

Use of any other tubes may lead to incorrect results or processing failures.

Pool tubes have an expiry date. Do not load expired pool tubes onto the pooling instrument.

Pool tubes are delivered with a barcode label. The barcodes for pool tubes start with a dollar sign ($) and are nine characters long (including the dollar sign and the checksum character).


72 Consumables

Pipette tips

Disposable 1000 μ L pipette tips are used for pipetting liquids. Filters are used to prevent carryover by aerosols.

The pipette tips are available in tip racks of 96 pipette tips each. Tip racks are placed into tip rack carriers.

u

Tip rack carrier (69)



73

Aliquot plates

Dimensions and position of the barcode label on aliquot plates

C B C

E

F

D

100 2489

A

To create aliquots of the samples, use commercially available multiwell plates that fit with the aliquot plate carrier and can hold at least 1 mL aliquots. For example

2.2 mL multiwell plates with 96 wells can be used.

Open the primary packaging of the aliquot plate before use.

Always use empty aliquot plates.

The dimensions of the barcode label on aliquot plates must be as follows:

A

Label length: max. 66 mm

B

Code length: max. 30 mm

C

Quiet zone: min. 3 mm

D

Label width: min. 10 mm

E

Code width: min. 7 mm

F

Distance from code to label edge: max. 1 mm y

Barcode label dimensions on aliquot plates

Place the barcode label centered on the right short side of the aliquot plate so that it can be read during plate loading.

Make sure that the barcode is parallel to the edge of the plate and that it does not protrude above or below the aliquot plate edges.

Always use unique barcode IDs for aliquot plates.


74 External PC

External PC

Workstations run the data manager in a client-server architecture. Each pooling instrument is controlled by a control unit running the pooling instrument manager.

Hand-held barcode readers are connected to each control unit to allow manual barcode reading.

The status light of the pooling instrument is connected to the control unit running the pooling instrument manager.


Overview of cobas Synergy software

Table of contents

75

4

In this chapter

4

About the data manager . . . . . . . . . . . . . . . . . . . . . . . .

77

Main structure of the software . . . . . . . . . . . . . . . .

77

Global information area . . . . . . . . . . . . . . . . . . . . . .

78

Message section. . . . . . . . . . . . . . . . . . . . . . . . .

79

User section. . . . . . . . . . . . . . . . . . . . . . . . . . . . .

82

Database section . . . . . . . . . . . . . . . . . . . . . . . .

83

System section . . . . . . . . . . . . . . . . . . . . . . . . . .

83

Work area. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

84

About panels . . . . . . . . . . . . . . . . . . . . . . . . . . . .

85

About navigation. . . . . . . . . . . . . . . . . . . . . . . . .

85

Sorting and filtering data in tables . . . . . . . . . .

86

About the pooling instrument manager . . . . . . . . . . .

88

Main structure of the software . . . . . . . . . . . . . . . .

88

Global information area . . . . . . . . . . . . . . . . . . . . . .

89

Work area. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

90

About navigation. . . . . . . . . . . . . . . . . . . . . . . . .

91

About user management. . . . . . . . . . . . . . . . . . . . . . . .

92

About the User Assistance . . . . . . . . . . . . . . . . . . . . . .

93

Using the User Assistance in the data manager .

93

Using the User Assistance in the pooling instrument manager. . . . . . . . . . . . . . . . . . . . . . . . .

94

Using the User Assistance in a browser . . . . . . . .

94

Using the User Assistance on an offline PC . . . . .

95

Disabling/enabling the navigation history of the

User Assistance . . . . . . . . . . . . . . . . . . . . . . . . . . . .

96


76

Table of contents



77

About the data manager

Double-click the desktop icon to start the data manager.

In this section

Main structure of the software (77)

Global information area (78)

Work area (84)

Main structure of the software

The software has the following main structure:

• Global information area

• Work area

A

B

C

A

Global information area

B

Work area w

Main structure of the software

Global information area

C

Software version

D

Date and time

D

In the global information area, you can access messages, connection information, and system configuration.

The global information area may vary, depending on the user rights of the user currently logged on.


78 About the data manager

Work area

Footer

In the work area, you can access the tabs, the navigation bar, and the panels.

The footer provides information about the version of the software, date, and time.

u

Related topics

• Global information area (78)

• Work area (84)


The global information area is always visible. It is divided into sections that display system information. Choose the section to access corresponding functions. Which function is available depends on the user rights of the user currently logged on.

The global information area consists of the following sections:

• Message section

• User section

• Database section

•

System

section

D A B

A

Message section

B

User section w Sections of the global information area

C

C

Database section

D System

section


Message section

Message indicator

Message panel


79

The message section has the following functions:

• Indicating occurrence, severity, and number of messages via the message indicator

• Accessing the message panel q

Refer to the troubleshooting section if you are unsure how to resolve from an error.

u

Creating messages (294)

The message section features a color-coded message indicator to alert you to messages. The color corresponds to the message with the highest severity level:

• Red:

There are error messages. There may be warning and general messages as well.

• Orange:

There are warning messages. There may be general messages as well.

• Yellow:

There are general messages.

The number next to the message indicator denotes the number of messages that require user action.

Choose the message section to open the message panel.

The message panel shows messages in detail. You can perform actions on messages using the message action buttons.



A

B

C

D E

A

Message action buttons

B

Message tabs

C

Message table w

Message panel

D

Number of selected messages

E

Total number of non-acknowledged (

NAK

) messages and acknowledged (

ACK

) messages (if set to show)

Message tabs

The message tabs arrange messages according to their severity:

• Error messages

• Warning messages

• General messages

The numbers on the message tabs (i.e.

1/0

) indicate the number of non-acknowledged messages and the number of acknowledged/deleted messages (if set to show) on that tab.

Choose a tab to display the corresponding messages in the message table.

Message table

In the message table, messages are displayed according to their status:

• Non-acknowledged messages: bold, blue

• Acknowledged messages: regular, blue

• Deleted messages: regular, gray

By default, only non-acknowledged messages are displayed. To display acknowledged and deleted messages as well, choose the corresponding message action buttons.



81

A

B

C

A

Non-acknowledged message

B

Acknowledged message w

Message table

C

Deleted message

The message table consists of the following columns:

•

ID

:

The ID of the instrument or system (if applicable) and the message text.

•

Date/Time

:

Date and time the message was generated.

•

Acknowledged

:

Date, time and user name of message acknowledgment.

•

Comment

:

If a message is configured to require user name entry for acknowledgment, you can enter an optional comment in the

Confirm user details

dialog box.

•

Source

:

Component or function of

cobas Synergy

solution that generated the message, for example:

-

Analyzer Manager

(interface to

cobas

®

6800/8800 Systems)

-

Pooling Manager

(interface to pooling instrument manager)

-

System

(data manager)

Choose a column header to sort message entries.



Message action buttons

In the message panel, the following action buttons are available:

•

Acknowledge

:

Choose to acknowledge selected messages.

•

Delete

:

Choose to delete selected messages.

You have to acknowledge messages first to be able to delete them.

•

Acknowledge & Delete

:

Choose to acknowledge and delete selected messages.

•

Show deleted

:

Choose to display deleted messages in the message table.

If you set deleted messages to show, the button displays a blue background.

You have to display acknowledged messages first, to be able to display deleted messages as well.

•

Show ACKed

:

Choose to display acknowledged messages in the message table.

If you set acknowledged messages to show, the button displays a blue background.

q

Depending on access rights, some action buttons may be disabled.

u

Related topics

• Creating messages (294)

• Managing users on the data manager (322)

User section

The user section has the following functions:

• Identifying the user currently logged on

• Changing the password

• Logging off u

Related topics

• Starting up and logging on to the data manager (123)

• Securing the system (124)


Database section

System section


83

The database section has the following functions:

• Identifying the active database

• Changing the database u

Related topics

• Starting up and logging on to the data manager (123)

The

System

section has the following functions:

• Accessing the Configuration environment and the

Manager environment for advanced configuration of the data manager.

• Creating a problem report

• Accessing general information

• Shutting down the data manager u

Related topics

• The Configuration environment (283)

• The Manager environment (299)

• Creating a problem report in the data manager (234)

• Shutting down the system (183)



Work area

A

B

C

D

The work area is the center of your activities when working with the software.

A

Tabs

B

Navigation bar with (back), (forward) buttons and navigation path w

Work area

C

Task button

D

Panel

The work area contains the

Routine

tab, the

Reports

tab, and the

Administration

tab. Tabs are used to group information and software functions into units that can be displayed on one screen. Each tab has a navigation bar at the top and displays the panels.



85

About panels

A

B

A panel is an organizational unit within a tab.

D

E

F

C

A

Main panel

B

Task button

C

Panel splitter to adjust panel width w Main panel on the left and detail panel on the right

Main panel

D

Detail panel

E

Table

F

Buttons

Detail panel

Choose a tab to display the main panel. The main panel contains the task buttons corresponding to steps in the overall blood screening workflow.

Choose a task button to open the detail panel. The detail panel displays detailed information and contains buttons to perform tasks on selected elements.

About navigation

The navigation bar is positioned at the top of the work area above the panels. It contains these navigation aids:

• Back and forward buttons:

While navigating through the work area, each location is automatically stored in a browse history. To browse the history, use the back and forward buttons on the navigation bar.

• Navigation path:

The path from the tab to the current location is shown as a navigation path in the navigation bar. Choose a path element to go back to that location.



Sorting and filtering data in tables

About sorting

About filtering

In the data manager, you can sort and filter data displayed in tables.

You can sort a table by a column in ascending or descending order. The following rules apply:

• You cannot sort by more than 1 column.

• You can filter the sorted table.

• When you navigate to a different panel, the sort order is lost.

You can filter data using a simple text search. The following rules apply:

• The filter becomes effective immediately when you type the first letter of the search text.

• As the search result, you get all table entries that contain the search text. Not only the entries that start with the search text.

• You can combine filters in different columns.

• You can sort the filtered table.

• The search is not case-sensitive.

• You cannot use the asterisk (*) as a wildcard.

• There are no predefined or default filters available.

You cannot save a custom filter.

• When you navigate to a different panel, the filter is lost.

2

r

To sort data in a table

1

Navigate to a table on a detail panel.

2

To sort the table by a column in ascending order, choose the column header.

f

A triangle above the column header indicates the sorting column and the sorting order.

3

3

To change to descending sort order, choose the column header a second time.



87

4

4

To restore the default sort order, choose the column header a third time.

2

r

To filter data in a table

1

Navigate to a table on a detail panel.

2

To filter the table, place the mouse cursor above a column header. Choose the search field displayed next to the column header.

3

3

In the search field, enter the search text. f

The matching table entries are displayed.

4

To delete a filter, delete the search text from the search field.

f

All table entries are displayed again.

5

To cut, copy, and/or paste search text, right-click in the search field, or press Ctrl+X, Ctrl+C, or Ctrl+V.


88 About the pooling instrument manager

About the pooling instrument manager

Double-click the desktop icon to start the pooling instrument manager.

In this section

Main structure of the software (88)

Global information area (89)

Work area (90)

Main structure of the software

The software has the following main structure:

• Global information area

• Work area

A

B

C

A


B

Work area w

Main structure of the software

C

Date and time


In the global information area, you can access user and system information.



89

Work area

In the work area, you can access the tabs and the

Maintenance

group box.


A

B

A

Software name and version

B

Currently logged on user

C D

C Switch user

button

D

Information button

The global information area is always visible. It shows the user currently logged on and gives access to the following functionalities:

• To switch to a different user, choose the

Switch user

button (disabled during pooling run).

The

Logon

dialog box is displayed for you to enter user name and password.

• To display the

About

dialog box, choose


90 About the pooling instrument manager

Work area

The work area is the center of your activities when working with the software.

A

B

C

E

D

A

Tabs

B

Navigation bar

C

Task button w Work area

F

D Maintenance

group box

E

Panel

F

Button

The work area contains the

Routine

tab, the

Administration

tab, and the

Service

tab. Tabs are used to group information and software functions into units that can be displayed on one screen.

q

Access to the tabs depends on user rights.

u

Managing users on the pooling instrument manager (249)

Each tab has a navigation bar at the top and displays the panel corresponding to the current location in the navigation path.

Additionally, the

Routine

tab displays the

Maintenance

group box.


About navigation


91

The navigation bar is at the top of the work area above the panel. It shows the navigation path from the tab to the current location. Choose a path element to go back to that location.


92 About user management

About user management

User management on the data manager

User management on the pooling instrument manager

User management on the analytic system

User management for the

cobas Synergy

solution is done separately on the data manager, the pooling instrument manager, and the analytic system.

Users for the data manager are created and edited in the

Manager environment of the data manager. You can assign predefined security levels or individual menu restrictions.

u


Users for the pooling instrument manager are created and edited on the

Administration

tab of the pooling instrument manager using the

User management

task button.

u

Managing users on the pooling instrument manager (249)

Users for the analytic system are created and edited on the

Administration

tab of the analytic system software using the

User management

task button.

q

To be able to release the results on the analytic system to the pooling instrument, it is recommended to create a new user group combining the roles of operator and technical validator.

u

cobas

®

6800/8800 Systems User Assistance



93

About the User Assistance

The User Assistance includes the content of the User

Guide and the Safety Guide. Additionally, the User

Assistance includes the following information:

• Troubleshooting information

• Configuration information

• Additional information in the system description

In this section

Using the User Assistance in the data manager (93)

Using the User Assistance in the pooling instrument manager (94)

Using the User Assistance in a browser (94)

Using the User Assistance on an offline PC (95)

Disabling/enabling the navigation history of the User

Assistance (96)

Using the User Assistance in the data manager

In the current software version, the User Assistance is accessible from the data manager.

The User Assistance can also be used on an external device such as a PC or a mobile tablet device.

r

To access the User Assistance in the data manager

1

Press F1.

f

The User Assistance is displayed.

2

Optionally in the Configuration environment or the

Manager environment, do the following:

• Choose

Help > Contents

.

• Choose

Help > Search

.

• Choose the button.

f

The User Assistance is displayed.

u

Related topics

• Using the User Assistance in the pooling instrument manager (94)

• Using the User Assistance in a browser (94)

• Using the User Assistance on an offline PC (95)

• Disabling/enabling the navigation history of the User

Assistance (96)


94 About the User Assistance

Using the User Assistance in the pooling instrument manager

In the current software version, the User Assistance is not accessible from the pooling instrument manager.

The User Assistance can be used on an external device such as a PC or a mobile tablet device.

u

Related topics

• Using the User Assistance in the data manager (93)




Assistance (96)

Using the User Assistance in a browser

Offline usage

Updates

While online, content is downloaded to the browser cache. Due to limitations of the cache space, not all content remains available offline.

When online, the User Assistance notifies if updates are available.

d m

Mobile tablet device or PC m

Connection to the Internet m

Apple Safari (tested for iPad only) or Google Chrome browser (tested for Windows 7 only) r

To use the User Assistance in a browser

1

In your browser, enter the link to the User Assistance.

I

Link, user name, and password are provided by your Roche Service representative.

2

Enter user name and password.

3

Open the User Assistance.



95

u

Related topics





Assistance (96)

Using the User Assistance on an offline PC

d m

PC m

Standalone package of the User Assistance r

To use the User Assistance on an offline PC

1

Copy the standalone package of the User Assistance to your PC.

2

Double-click the installation file.

3

To start the User Assistance next time, double-click the icon on your desktop.

u

Related topics





Assistance (96)


96 About the User Assistance

Disabling/enabling the navigation history of the User

Assistance

If your are accessing the web-based User Assistance in the browser, the User Assistance records the user navigation history (anonymously).

The user navigation history can be used to understand the users’ needs better and to improve our documentation. You can disable the navigation history.

2

r

To disable/enable the navigation history

1

On the global navigation bar, choose the button.

2

To disable the navigation history, choose the

Do not save navigation history

option.

3

To enable the navigation history, do the following:

• Choose the

Save navigation history anonymously

option to save your navigation history anonymously.

• Choose the

Save navigation history

option to save your navigation history and IP address. If you enter your contact details, they are saved together with your navigation history. This information can be used for troubleshooting.

u

Related topics






Table of contents

97

Description of the pooling process

5

In this chapter

5

Overview of pooling process. . . . . . . . . . . . . . . . . . . . .

99

Primary pools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100

Primary pools of 6. . . . . . . . . . . . . . . . . . . . . . . . . . . 100

Primary pools of 24. . . . . . . . . . . . . . . . . . . . . . . . . . 100

Primary pools of 96. . . . . . . . . . . . . . . . . . . . . . . . . . 100

Secondary pools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

Secondary pooling for reactive pools. . . . . . . . . . . 101

Repeat pools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103

Individual donor testing (IDT) . . . . . . . . . . . . . . . . . . . . 104

Aliquots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105

Exclusion lists . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106


98

Table of contents



99

Overview of pooling process

1

PP6

2

IDT

Primary pooling

1

PP24

2

SP6

3

IDT

Pool resolution

1

PP96

2

SP6

3

IDT

In blood screening, samples are combined into pools to increase testing efficiency. The Microlab creates pools of 6, 24, and 96 samples.

®

STAR IVD

After the pools are created, they are analyzed on the

cobas

®

6800/8800 Systems.

Primary pool

(PP)

Secondary pool

(SP)

A secondary pool has a pool size of 6 and is also created directly from sample tubes. It is triggered by a pool having a reactive result or by a change request by the user.

Repeat pool

A primary pool is created directly from sample tubes for first-time analysis.

Individual donor testing

(IDT)

A repeat pool is triggered by any invalid result of a primary or secondary pool. A repeat pool has the same pool size as the previously invalidated pool.

An IDT is the last step in the resolution workflow. No pooling is done. The sample is directly placed on the

cobas

®

Systems.

6800/8800


100 Primary pools

Primary pools

Primary pools of 6

The pooling instrument unifies aliquots of multiple samples into a pool.

Pools of 6, 24, and 96 samples can be generated.

An aliquot is aspirated from 6 sample tubes and dispensed into a pool tube.

The pipetting volume per sample is 374 μ L.

Primary pools of 6 allow ordering of up to two tests.




Primary pools of 24 allow ordering of up to two tests.




Primary pools of 96 allow ordering of up to 4 tests.



101

Secondary pools

Secondary pools are used to resolve reactive primary pools.

A secondary pool allows ordering of one test only.

Secondary pooling for reactive pools

If a primary pool is reactive, secondary pools are then prepared containing aliquots that are represented in the reactive primary pool. The secondary pools are then tested to identify a smaller group of samples that caused the primary pool to be reactive.

Reactive primary pool of 6

Reactive PP6

If a primary pool of 6 is found to be reactive, the samples are measured directly on the analytic system (IDT).

1

IDTs

6 u IDT measured directly on the analytic system

Yes

2

IDT reactive?

No

Sample is reactive for one or more tested targets

Sample is non-reactive for all tested targets


102 Secondary pools


Reactive PP24

1

Secondary pools

SP6 from samples

Yes

2

SP6 reactive?

No

If a primary pool of 24 is found to be reactive, secondary pools of 6 are prepared from the samples. If a secondary pool of 6 is found to be reactive, it is resolved by measuring the samples directly on the analytic system

(IDT).

The sample pipetting volume for a secondary pool of 6 is

200 μ L.

3

IDTs

6 u IDT measured directly on the analytic system

Yes

4

IDT reactive?

No


Samples of the pool are non-reactive for all tested targets


Reactive PP96

1

Secondary pools

SP6 from sample

Yes

2

SP6 reactive?

No

If a primary pool of 96 is found to be reactive, secondary pools of 6 are prepared. If a secondary pool of 6 is found to be reactive, it is resolved by measuring the samples directly on the analytic system (IDT).

3

IDTs

6 u

IDT measured directly on the analytic system

Yes

4

IDT reactive?

No


Samples of the pool are non-reactive for all tested targets


Repeat pools


103

When test results for a pool are invalid, or when a pool was manually rejected after preparation, a repeat pool is prepared.

Repeat pools are prepared from sample tubes.

u

Related topics

• Evaluating pending pools (152)


104 Individual donor testing (IDT)

Individual donor testing (IDT)

In individual donor testing (IDT), the sample is directly placed on the analytic system without creating a pool on the pooling instrument.

Individual donor testing is done as the last step in the resolution workflow or in cases where the sample is placed directly on the analytic system, without pooling.

For individual donor testing, use sample volume as specified in the

cobas

®

Assistance.

6800/8800 Systems User u

Related topics

• Exclusion lists (106)


Aliquots


105

Aliquots are created in aliquot plates.

The pooling instrument creates aliquots in dedicated aliquot runs.

In an aliquot run, 1 mL is transferred from the sample tube to an aliquot plate well. Multiple aliquots of the same sample can be prepared in subsequent aliquot runs.


106 Exclusion lists

Exclusion lists

Add a sample to one of the exclusion lists to exclude it from pooling. Excluded samples can directly be placed on the analytic system as IDT.

Excluded samples are set to the

Invalid

status and are listed in the

Pending pools

panel. In the details of the

Sample History

panel, excluded samples are indicated as

Sample on the exclusion list

.

If a sample is excluded, all pooling orders from that sample are affected. No automatic re-scheduling is done for the orders of excluded samples.

Exclusion list for

Seropositive samples

Explanation

Exclusion list for samples that are known to be seropositive or that are expected to be seropositive.

Samples with WNV test orders Exclusion list for samples with a WNV test order. WNV infections are seasonal and need to be tested as IDT during a certain time in the year or in case of local infections.

y Exclusion lists

(1) YY=year, MM=month, DD=day, hh=hours, mm=minutes

Default location

C:\SeroPos

C:\WNV

File name

(1)

Serology_YYMMDD-hhmm.csv

IDT_YYMMDD-hhmm.csv

The default location of the exclusion lists can be changed in the

General settings

panel.

u

Related topics

• Global settings group box (273)


Specifications

Table of contents

107

6

In this chapter

6

List of pooling instrument specifications . . . . . . . . . . 109

Power rating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

Environmental conditions . . . . . . . . . . . . . . . . . . . . 109

Dimensions and weight . . . . . . . . . . . . . . . . . . . . . . 110

Space required around the pooling instrument . . 110


108

Table of contents


Specifications

109

List of pooling instrument specifications

In this section

Power rating (109)

Environmental conditions (109)

Dimensions and weight (110)

Space required around the pooling instrument (110)

Power rating

NOTICE

Risk of damage to the instrument

r Connect only to earth grounded outlet.

The power supply must fulfill the following requirements.

Never operate the pooling instrument if one of the requirements is not fulfilled.

Value

115 V AC (±10%), 50/60 Hz (±5%)

230 V AC (±10%), 50/60 Hz (±5%)

Power rating

y

Electric power supply

Environmental conditions

Ambient temperature

Ambient humidity

Air pressure

During operation

Transportation and storage

During operation


During operation


The location must comply with the following conditions.

Never operate, transport, or store the pooling instrument if one of the environmental conditions is not fulfilled.

International (Europe)

15–30 °C

-25 °C to +70 °C

US / Canada

59–86 °F

-13 °F to +158 °F

15–85% (non-condensing)

10–90% (non-condensing)

106–80 kPa (Altitude above sea level: 0–2000 m)

106–80 kPa (Altitude above sea level: 0–2000 m) y

Environmental conditions


110 List of pooling instrument specifications

Dimensions and weight

Length

Width

Height

Weight

y Dimensions and weight

The pooling instrument has the following dimensions

(footprint) and weight:

Without trolley

Without trolley, without autoload tray

(transport size)

Without trolley, with autoload tray

Without trolley, with carrier on the autoload tray

Without trolley

Without trolley

Value

166.4 cm

79.5 cm

100.6 cm

120 cm

90.3 cm

145 kg

Space required around the pooling instrument

Front

Minimum space required

100 cm y Space required around the pooling instrument

Do not operate the pooling instrument if there is not sufficient free space around it.


System operation

7 Workflow overview...............................................................................................113

8 Before operation ...................................................................................................119

9 Operation.................................................................................................................125

10 After operation ......................................................................................................181

11 Maintenance ..........................................................................................................187

12 Quick references ..................................................................................................207


Workflow overview

Table of contents

113

7

In this chapter

7

Workflow for PP24 and PP96 pooling runs . . . . . . . . . 115

Workflow for PP6 pooling runs . . . . . . . . . . . . . . . . . . . 116

Workflow for aliquot runs . . . . . . . . . . . . . . . . . . . . . . . 117


114

Table of contents



115

Workflow for PP24 and PP96 pooling runs

The following figure shows an overview of the workflow for PP24 and PP96 pooling runs.

6DPSOHSUHSDUDWLRQ

Obtain donor samples

3RROLQJLQVWUXPHQW

PDQDJHU

2YHUYLHZZRUNÁRZIRU33DQG33

3RROLQJLQVWUXPHQW 'DWDPDQDJHU

Perform startup procedures

$QDO\WLFV\VWHP

Load reagents

Perform pooling run

Store samples

Review pooling run status:

Pooling run status report

Samples to reload report

Transfer pools to analytic system

IDT after SP6

Transfer samples to analytic system

Reload samples for SP6 after PP24/PP96 w

Workflow for PP24 and PP96 pooling runs

Perform sample prepa-

UDWLRQDPSOLÀFDWLRQ detection

Review run status:

Results for review

Pending pools

Pending tests

If necessary, identify samples for:

Secondary pooling run (after PP24/PP96)

IDT (after SP6)

SP6


116 Workflow for PP6 pooling runs

Workflow for PP6 pooling runs

The following figure shows an overview of the workflow for PP6 pooling runs.

Sample preparation


3RROLQJLQVWUXPHQW

PDQDJHU

2YHUYLHZZRUNÁRZIRU33

3RROLQJLQVWUXPHQW 'DWDPDQDJHU


$QDO\WLFV\VWHP

Load reagents

Perform pooling run

Store samples

Review pooling run status:

Pooling run status report

Samples to reload report

Transfer pools to analytic system

IDT

Perform sample prepa-

UDWLRQDPSOLÀFDWLRQ detection

Review run status:

Results for review

Pending tests

Identify samples for IDT (if necessary)

Transfer samples to analytic system w Workflow for PP6 pooling run



117

Workflow for aliquot runs

The following figure shows an overview of the workflow for aliquot runs.

2YHUYLHZZRUNÁRZIRUSUHSDULQJDOLTXRWV

3RROLQJLQVWUXPHQWPDQDJHU 3RROLQJLQVWUXPHQW 6DPSOHSUHSDUDWLRQ



Perform aliquot run

Store samples w Workflow for aliquot runs


118 Workflow for aliquot runs


Before operation

Table of contents

119

8

In this chapter

8

Starting up and logging on . . . . . . . . . . . . . . . . . . . . . . 121

Starting up the pooling instrument and software 121

Starting up and logging on to the data manager. 123

Securing the system. . . . . . . . . . . . . . . . . . . . . . . . . 124


120

Table of contents



121

Starting up and logging on

To start up the system, switch on the Microlab

®

STAR IVD instrument, the control unit for the pooling instrument manager, and the workstation for the data manager.

In this section

Starting up the pooling instrument and software (121)

Starting up and logging on to the data manager (123)

Securing the system (124)

Starting up the pooling instrument and software

To start up the pooling instrument, switch on the

Microlab

®

STAR IVD instrument and the control unit running the pooling instrument manager.

The system is typically not turned off at the end of a shift.

1

r

To start up the instrument

1

NOTICE Before powering on the instrument, check the instrument deck for any carriers or consumables still loaded and remove them.

1 To switch on the instrument, press the power switch.

2

2

Make sure the safety guards on both sides of the autoload tray are extended.


122 Starting up and logging on

r

To start up and log on to the pooling instrument manager

1

Switch on the control unit.

2

On the control unit desktop, double-click the pooling instrument manager icon.

3

3

In the

Logon

dialog box, enter the user name and password and choose the

Log on

button.

4

4

Perform any maintenance actions that the

Maintenance

group box displays as being required.

u

Related topics

• Periodic maintenance (190)



123

Starting up and logging on to the data manager

To start up the data manager, switch on workstation and then start and log on to the data manager.

The system is typically not turned off at the end of a shift. r

To start up and log on to the data manager

1

If the workstation and server are off, perform the following steps:

• At the front of the server, press the button.

• Ensure that the workstation monitor is switched on.

• After the server has completed booting, log on with your user password.

2

On the workstation desktop, double-click the data manager icon.

3

3

In the

Logon

dialog box, enter the user and password and choose the

Logon

button.

4

4

In the

Select database

dialog box, select the database to be used and choose the

OK

button.


124 Starting up and logging on

Securing the system

2

To secure the system you can either log off (data manager only) or use the lock function of the operating system.

It is recommended to secure the system when leaving the instrument unattended for any length of time.

r

To secure the software

1

To close the pooling instrument manager, choose the close button at the top right of the main work area or press Alt+F4.

2

To log off from the data manager, at the top of the work area, expand the user menu and choose the

Log off

option.

3

To lock the workstation or control unit, perform one of the following:

• Press Ctrl+Alt+Delete, then choose the

Lock this computer

option.

• Press +L.

I

You can unlock the workstation or control unit by pressing Ctrl+Alt+Delete and then entering your password.


Operation

Table of contents

125

9

In this chapter

9

Basic operational tasks . . . . . . . . . . . . . . . . . . . . . . . . . 127

Loading and unloading carriers . . . . . . . . . . . . . . . 127

Loading sample tubes . . . . . . . . . . . . . . . . . . . . . . . 129

Loading pool tubes. . . . . . . . . . . . . . . . . . . . . . . . . . 130

Loading aliquot plates . . . . . . . . . . . . . . . . . . . . . . . 131

Preparing a tip rack carrier . . . . . . . . . . . . . . . . . . . 132

Checking pools before analysis . . . . . . . . . . . . . . . 132

About the solid waste container. . . . . . . . . . . . . . . 133

Pooling operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134

Pipetting overview . . . . . . . . . . . . . . . . . . . . . . . . . . 134

About pre-analytical systems . . . . . . . . . . . . . . . . . 135

About the analytic system . . . . . . . . . . . . . . . . . . . . 135

Creating a pool . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136

Preparing aliquot plates. . . . . . . . . . . . . . . . . . . . . . 141

Preparing aliquot plates. . . . . . . . . . . . . . . . . . . 141

Storing samples . . . . . . . . . . . . . . . . . . . . . . . . . 145

Evaluating the workflow progress . . . . . . . . . . . . . 146

List of pool details . . . . . . . . . . . . . . . . . . . . . . . 147

Evaluating pending pools . . . . . . . . . . . . . . . . . 152

Evaluating pending tests . . . . . . . . . . . . . . . . . . 154

Evaluating results for review . . . . . . . . . . . . . . . 157

Evaluating sample history . . . . . . . . . . . . . . . . . 160

Evaluating aliquot plates . . . . . . . . . . . . . . . . . . 162

Handling a pool when not all samples were confirmed. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163

Handling invalid pools . . . . . . . . . . . . . . . . . . . . . . . 165

Changing pooling orders for secondary and repeat pools. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167

Creating secondary and repeat pools . . . . . . . . . . 168

Repeat testing on the analytic system after an invalid test result. . . . . . . . . . . . . . . . . . . . . . . . . . . . 169

Handling invalid HAV results due to samples with high B19 titer . . . . . . . . . . . . . . . . . . . . . . . . . . 171

Searching samples . . . . . . . . . . . . . . . . . . . . . . . . . . 173

Reporting in the data manager. . . . . . . . . . . . . . . . . . . 174

Report types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174

cobas Synergy reports . . . . . . . . . . . . . . . . . . . . . . . 175

Alarm report . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176

Operation reports . . . . . . . . . . . . . . . . . . . . . . . . 176

Quality reports. . . . . . . . . . . . . . . . . . . . . . . . . . . 177

Creating a cobas Synergy report . . . . . . . . . . . 178


126

Table of contents

Handling reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . 179


Operation

127

Basic operational tasks

Ensure that daily maintenance has been performed.

u

Performing daily maintenance (191)

In this section

Loading and unloading carriers (127)

Loading sample tubes (129)

Loading pool tubes (130)

Loading aliquot plates (131)

Preparing a tip rack carrier (132)

Checking pools before analysis (132)

About the solid waste container (133)

Loading and unloading carriers

Carriers are manually placed on the autoload tray. From there, the autoloader loads them onto the instrument deck.

q

All carrier types are loaded and unloaded in the same way.

The pooling instrument manager displays a message indicating the carrier types and their loading position on the autoload tray.

1

2

r

To load and unload carriers

1

Check the pooling instrument manager for the type and location of carrier to be loaded.

2

CAUTION! Risk of personal injury due to contact with spilled samples.

Ensure that no carriers are loaded onto tracks with carriers loaded on the deck.

Make sure that the carrier is inserted completely until it touches the stop hooks.

Handle one-track carriers with particular care.

2 Place the carrier on the corresponding track of the autoload tray.


128 Basic operational tasks

4

3

NOTICE Risk of damage to instrument while loading.

Insert the carrier horizontally, with the slide blocks engaging the guiding rails of the carrier.

Insert the carrier carefully until it touches the stop hook on the far side of the autoload tray. Do not insert it further.

3 Insert the carrier horizontally on the autoload tray until it touches the stop hook.

• Make sure to insert the carrier on the correct track.

• The slide blocks must engage the guiding rails of the carrier.

• Do not insert the carrier beyond the stop hook on the far side of the autoload tray.

4

The autoload unit automatically loads the carrier onto the instrument. The barcodes of the carriers are read during loading.

5

Tube carriers are automatically unloaded to the autoload tray when pipetting is completed. Other carriers are unloaded at the end of the pooling run.


Operation

129

Loading sample tubes

This section describes loading sample tubes onto sample carriers.

If using gel tubes, visually check the sample volume above the gel before loading a tube on the pooling instrument or the analytic system.

If using non-gel tubes, verify that all samples have enough volume for testing.

c

As required.

d m

Sample tubes m

Empty sample carriers m

Lab coat m

Lab gloves m

Eye protection

2

r

To load sample tubes

1

CAUTION! Infection by biohazardous material.

Use caution when handling and processing donor samples.

1 Decap the sample tubes, ensuring that there is no leakage, foam, air bubbles, or clots.

2

Load sample tubes, starting in position 1 of the sample carrier.

I

For optimum performance, do not leave gaps between the tubes and do not leave empty positions at the end of the carriers (except for the last carrier loaded).

3

3

NOTICE Do not leave gaps between sample carriers.

As soon as a gap is detected, sample loading is completed.

3 Load the sample carrier, following the instructions of the pooling instrument manager.

u

Related topics


• Preparing aliquot plates (141)



Loading pool tubes

This section describes loading pool tubes onto a pool tube carrier.

c

As required.

d m

Pool tubes m

Pool tube carriers

2

r

To load pool tubes

1

CAUTION! Use only empty pool tubes to avoid contamination due to overflow.

1 Provide the required number of empty pool tubes with barcodes.

2

NOTICE Risk of damage due to incorrect loading.

5-position racks must be placed on the 5-position rack carrier so that the first rack is located immediately next to the carrier barcode.

2 Place the pool tubes in the pool tube carrier.

I

You can load pool tubes onto a 5-position rack carrier or a 32-position sample carrier.

3

3

Load the pool tube carrier in the designated tracks on the autoload tray.


Operation

131

Loading aliquot plates

This section describes loading aliquot plates onto carriers.

c

As required.

d m

Aliquot plates m

Aliquot plate carriers

1

r

To load aliquot plates

1

Inspect the plates for defects before placing them on the carrier.

2

2

Place the required number of aliquot plates on a plate carrier, starting in position 1.

• Do not leave gaps between the plates.

• Do not leave empty positions at the end of the carriers, except for the last carrier loaded.

3

3

Load the aliquot plate carrier in the designated tracks on the autoload tray. The plate carrier occupies 6 tracks.

u

Related topics

• Aliquot plates (73)



Preparing a tip rack carrier

The tip rack carrier holds up to 5 tip racks, each containing 96 pipette tips. d m

Empty tip rack carrier m

At least 5 tip racks

1

r

To prepare a tip rack carrier

1

Starting in position 1, place the required number of tip racks (up to 5) on a tip rack carrier. Do not leave gaps between the tip racks.

I

Tip racks are barcoded. The barcodes of the tip racks must face to the right of the carrier when they are loaded on the carrier.

u

Related topics


• Preparing aliquot plates (141)

Checking pools before analysis

A visual check of each pool must be done before analysis.

Critical pools must be rejected and the pool creation must be repeated using fresh samples.

If using gel tubes, visually check the sample volume above the gel before loading to a tube on the pooling instrument or the analytic system.

If using non-gel tubes, verify that all samples have enough volume for testing.

u

For details about procedural limitations of the tests, refer to the


of the tests for the

cobas

®

6800/8800 Systems.

r

To check the pools visually before analysis

1

After the pool tubes are unloaded, visually check each pool for consistent volume and red cell contamination.

2

To reject a pool, perform steps in ( u

152).


Operation

133

3

Repeat pooling run as required.

About the solid waste container

Empty the solid waste container regularly to ensure correct operation of the instrument.

NOTICE

System malfunctions due to solid waste overflow

Ignoring the task of emptying the solid waste may result in solid waste overflow and system malfunctions.

r Always empty the solid waste container when required.

Emptying the solid waste container is part of daily maintenance. If daily maintenance is not performed, it is not possible to operate the instrument.

u


q

To prevent punctures, always handle the solid waste bag with care.


134 Pooling operations

Pooling operations

The deck layout of the instrument (i.e. the position of all carriers on the deck) is specially configured for pooling and aliquot protocols.

In this section

Pipetting overview (134)

About pre-analytical systems (135)

About the analytic system (135)

Creating a pool (136)

Preparing aliquot plates (141)

Evaluating the workflow progress (146)

Handling a pool when not all samples were confirmed (163)

Handling invalid pools (165)

Changing pooling orders for secondary and repeat pools (167)

Creating secondary and repeat pools (168)



B19 titer (171)

Searching samples (173)

Pipetting overview

The Microlab

®

STAR IVD instrument is programmed to pipette the following pipetting types for the

cobas Synergy

solution.

Pipetting type

Primary pool

Aliquot plate

Description

A pool of n-samples created for initial sample testing. Primary pools containing up to 96 samples are always prepared in 1 pooling run.

2 tests can be configured for primary pools of 6 and 24. Up to 3 tests can be configured for primary pools of 96.

A deepwell plate containing a single aliquot of a sample per well. This plate is for long-term storage and cannot be run on the

cobas Synergy

solution for further testing.

y

Pipetting configurations

The Microlab

®

STAR IVD contains 8 air-displacement pipetting channels working in parallel for simultaneous pipetting of up to 8 samples. The number of pipetting channels used during a pooling run depends on the type and size of the pool being pipetted.


Operation

135

About pre-analytical systems

Pre-analytical systems interface

Carriers with pre-analytical systems

This section describes support of pre-analytical systems by the

cobas Synergy

solution.

The

cobas Synergy

solution supports integrating preanalytical systems for pre-analytical tasks. The preanalytical systems interface implements an ASTM host interface. Data reporting from pre-analytical systems is consolidated in sorting lists sent to the

cobas Synergy

solution interface.

q

Some pre-analytical systems require using only a

75 position collapsible pool carrier.

About the analytic system

Manual ordering

Rack-based ordering

Final B19 and DPX test results

This section describes requirements for using the

cobas

®

6800/8800 Systems with the

cobas Synergy

software.

Manual orders are not tracked by the

cobas Synergy

solution.

For manual ordering information, refer to the user documentation of the

cobas

®

6800/8800 Systems.

When using the

cobas Synergy

solution, rack-based test ordering on the

cobas

® disabled.

6800/8800 Systems must be

Final B19 and DPX test results are only available in the

cobas Synergy

software, and not on the

cobas

®

6800/8800 Systems.

The overall results displayed in the data manager can be

“N.R.” (non-reactive), although the same results are displayed as “Reactive” on the analytic system.

This happens because the data manager applies a

(configurable) titer cutoff value. The final B19 result can then be non-reactive in the data manager, even though the analytic system found B19 DNA in the respective sample.

u

Instrument titer cutoff (IU/mL) group box (274)



Creating a pool

Loading the pooling instrument

Sample collection

Perform startup procedures

Pools are created directly in one step from the samples.

u

Quick reference: Creating a pool y

(208)

The sample tubes are loaded first in order to calculate the number of the required supplies. Then, pipette tips and pool tubes are loaded.

NOTICE


r Do not switch off the instrument during a run.

r

Do not remove carriers from the instrument until they have been transferred back to the autoload tray.

A maximum of 768 samples can be loaded onto the pooling instrument for one run. This is also the optimum number of samples to achieve high throughput.

Samples can be loaded onto the pooling instrument for the first time. Or they can be reloaded if an error occurred during pipetting or to perform repeat pooling or secondary pooling.

For an overview of samples that need to be reloaded, refer to the Samples to reload report. u


q

For recommended instructions on sample collection, storage, and handling, see the test-specific


.

Equilibrate samples to room temperature before using.

u

Starting up and logging on (121)


Operation

137

2

r

To create a pool

1

Ensure that the data manager, pooling instrument manager, and instrument are running.

2

In the pooling instrument manager, on the

Routine

tab, in the

Start run - Select run settings

list, choose the type of pool to be performed.

3

3

Choose the

Start pooling

button.

• When prompted, enter your logon information.

• Choose the

Log on

button.

f

The

Start

panel is displayed.

4

4

NOTICE Ensure that sample tubes are decapped before loading.

4 Load the sample carriers onto the autoload tray as indicated on the

Start

panel. q

Sample carriers must always be loaded consecutively from left to right without a gap between them. As soon as a gap is detected, sample loading is completed.



5

5

At the bottom-right of the

Start

panel, choose the

Load sample tubes

button.

I

The pooling type is indicated at the bottom-left of the

Start

panel.

6

6

After sample loading has been confirmed, at the bottom-right of the

Sample confirmation

panel, choose the

Calculate supplies

button.

f

The

Supplies

panel is displayed, showing the number of required tip racks and pooling tubes, and showing the position on the autoload tray where they should be loaded.

7

7

Load the tip rack carriers into one of the positions indicated on the

Supplies

panel.

• Ensure that there are tip racks in all 5 positions of the tip rack carriers.

8

8


Supplies

panel, choose the

Load pipette tips

button.

I

All tip rack positions must be filled. If an empty position is detected, an error message appears and the carrier must be reloaded. Partially filled or empty tip racks are allowed.


Operation

139

9

9

After tip rack carrier loading, a dialog box for the detailed pipette tip information is displayed.

If necessary, you can optionally define the loading position range in the tip rack carrier. This feature allows you to use partially used tip racks.

I

If no entry is made within 15 s, this dialog box automatically closes.

10

10

NOTICE Do not reuse pool tubes.

10 Starting from the left-hand side of the area indicated on the

Supplies

panel, load the pool tube carriers.

11

11


Pipette tips

panel, choose the

Load pool tubes

button.

12

12

CAUTION! Personal injury due to contact with moving parts.

Do not place hands in the way of moving parts or on the instrument deck.

Keep your head and hands away from the working area the Microlab

®

STAR IVD instrument when it is in operation.

12 To start the pooling run, at the bottom-right of the

Confirm pools

panel, choose the

Pipetting

button.



13

13

To view the pipetting status of samples on sample carrier, in the

Sample carrier

list on the

Pipetting

panel, choose the sample carrier.

f

The pipetting status of the sample tubes on the carrier is displayed.

14

Optionally, do one of the following:

• To start a new pooling run, at the bottom-right of the

Pipetting

panel, choose the

Start new run

button.

• In the data manager, to determine follow-up actions for pools and samples, create the Pooling run status report and the Samples to reload report

as described in ( u

178).


Operation

141

Preparing aliquot plates

In this section

Preparing aliquot plates (141)

Storing samples (145)


Sample collection

Follow this procedure to transfer single sample aliquots to an aliquot plate.

u

Quick reference: Preparing aliquot plates y

(209)

To create several aliquots of a sample, repeat the aliquot run using the same sample.

NOTICE


r

Do not switch off the instrument during a run.

r Do not remove carriers from the instrument until they have been transferred back to the autoload tray.

q

For recommended instructions on sample collection, storage, and handling, see the test-specific


.

Perform startup procedures

Equilibrate samples to room temperature before using.

u


d m

Lab coat m Lab gloves m

Eye protection m Loaded sample carriers m

Loaded tip rack carriers m Loaded aliquot plate carriers. Up to 7 aliquot plates can be loaded for a run.



2

r

To prepare aliquot plates

1

Ensure that the data manager, pooling instrument manager, and instrument are running.

2

In the list of pool types, choose the

Aliquoting

option.

3

3

Choose the

Start pooling

button and enter your logon information.

f

The

Start

panel is displayed.

4

4

NOTICE Ensure that sample tubes are decapped before loading.

4 Load the sample carriers onto the autoload tray as indicated on the

Start

panel. q

Load beginning from the left-hand side of the autoload tray. Ensure that there are no gaps between rows. The instrument ceases loading if it encounters an empty row.


Operation

143

5

5


Start

panel, choose the


button.

I

The pooling type is indicated at the bottom-left of the

Start

panel.

6

6

After sample loading has been confirmed, at the bottom-right of the


panel, choose the


button.

f

The

Supplies

panel is displayed, showing the number of required tip racks and aliquot plates, and showing the position on the autoload tray where they should be loaded.

7

7


Supplies

panel, choose the


button.

I All tip rack positions must be filled. If an empty position is detected, an error message appears and the carrier must be reloaded. Partially filled or empty tip racks are allowed.

8

8

Load the tip rack carriers into one of the positions indicated on the

Supplies

panel.

• Ensure that there are tip racks in all 5 positions of the tip rack carriers.



9

9

After tip rack carrier loading, a dialog for the detailed pipette tip information is displayed.

If necessary, you can optionally define the loading position in the tip rack carrier.

I

If no entry is made within 15 s, this dialog box automatically closes.

10

10

Load the aliquot plate carriers into one of the positions indicated on the

Supplies

panel.

11

13

11


Pipette tips

panel, choose the

Load aliquot plates

button.

f

The

Aliquot plates

list displays all aliquot plates with barcodes and their corresponding loading status.

f

After successful loading of the aliquot plate carriers, the aliquot plates are confirmed automatically.

12

To handle loading errors, choose the

Confirm aliquot plates

button.

13

CAUTION! Personal injury due to contact with moving parts.

Do not place hands in the way of moving parts or on the instrument deck.

Keep your head and hands away from the working area the Microlab

®

STAR IVD instrument when it is in operation.

13 To begin the pipetting process, at the bottom-right of the

Aliquot plate confirmation

panel, choose the

Pipetting

button.

f

Samples are pipetted into aliquot plates and information is updated after each round of pipetting.


Storing samples

Operation

145

14

14

When the pipetting process is completed, all carriers are unloaded automatically. The

Sample carrier

table and the

Sample tube

table are displayed, showing the sample tube and pipetting statuses.

To return to the main window, at the bottom-right of the

Pipetting

panel, choose the

Start new run

button.

u

Related topics

• Loading sample tubes (129)

• Preparing a tip rack carrier (132)

• Loading aliquot plates (131)

This section describes storing aliquot plates and samples.

r

To store aliquot plates

1

Remove the aliquot plate from the plate carrier.

r

To store donor samples

1

For storage instructions, refer to the test-specific


.



Evaluating the workflow progress

Reports for evaluating results

This section describes the options and tools available for evaluating the workflow progress on the data manager.

u

Quick reference: Evaluating pool results y

(210)

The data manager includes the following

cobas Synergy

reports for additional result evaluation and determination of follow-up actions:

• For pooling results:

- Pooling run status report

- Samples to reload report

• For test results:

- Donor result report

- Invalid DPX pool results report

- Results to pooling run ID report

- Sample audit report u


In this section

List of pool details (147)

Evaluating pending pools (152)

Evaluating pending tests (154)


Evaluating sample history (160)

Evaluating aliquot plates (162)


Operation

147

List of pool details

Panel

Pending pools

Column

o

Sample ID

o

Status

y

List of pool details o

Run settings

o

Pool type

o

Pooling run ID

o

Pool size

o

Instrument

o

Rack

o

Position

This table lists the information available in the data manager tables.

Comments

Unique identifier of a sample.

Pending

: Samples loaded onto the pooling instrument for any pool run. Or samples from a reactive or invalid pool that have yet to be pooled.

Processing

: Samples that are currently being pooled; i.e. they are in the middle of a pooling run. Once the pooling run has completed all successfully pooled samples disappear from this list.

Invalid

: Samples are placed on the pooling instrument and are identified, but are not part of a pool tube.

Includes pool type, pool size, and test: e.g.

SP6_MPX

= secondary pool of 6 for MPX testing.

Primary pool

: First time test.

Secondary pool

: To be retested in a smaller pool size due to reactive result, invalid tests, or masked tests.

Identifier assigned to every pooling run in process and completed. Allows samples to be tracked within a pool.

Maximum number of samples in a pool according to run settings.

Pooling instrument ID.

Rack identifier (barcode).

Numbered position within rack.



Panel

Pending tests

o o o o

Column

o

Tube ID

o

Status

Test

Sample type

Pipetting volume [

Source

μ L]

o

Pool size

o

Pooled samples

o

Pooling run ID

o

Pooling instrument

o

Rack

o

Position

o

Pool creation date/time

Pending tests > Sample ID

o

Sample ID

o

Excluded

o

Reason for excluding

o

Mixing status

o

Pipetting status

y

List of pool details

Comments

Identifier of tube used. Can be a sample or a pool.

Processing

: Actual tube is identified and testing on the analytic system is started.

Pending

: Tube is ready on the pooling instrument and in transfer to the analytic system.

Test to be performed on the sample or pool.

Type of sample for the test to be performed.

Volume of sample for the test to be performed.

Indicates where the test order has come from:

Primary pool

Secondary pool

Default IDT

IDT resolution

Repeat pool

Repeat IDT

Maximum number of samples in a pool according to run settings.

Actual number of samples in pool.


Name of the pooling instrument.

Rack identifier (barcode).

Numbered position within rack.

Date and time pool was created.


Sample ID not in the pool.

Reason the sample is not included in the pool (e.g. pipetting error).

Numerical value indicating if mixing was successful.

Numerical value indicating if the pipetting was valid or not.


Operation

149

Panel


y

List of pool details o o o o o o o

Column

o

Tube ID

o

Pooled samples / Pool size

Pooling run ID

Titer value

Flags

o

Test

o

Analysis date/time

Overall result

Result status

Validated by

o

Validated on

o

Transmitted by

Transmitted date/time

o

Processing duration

(hours:minutes)

Comments

Pool ID or Sample ID.

o

Number of samples in a pool. Actual pool size is always less than or equal to the configured pool size.

o

Maximum number of samples in a pool (defined in the run settings in the pool order). Can only be 96,

24, or 6.


Number provided by the analytic system that indicates the severity of infection.

Result flag descriptions are those provided in the

cobas

®

6800/8800 Systems

Host Interface Manual

.

Test to be performed on the sample or pool.

Date and time the sample was analyzed.

NR

: Non-reactive

Reactive

Complete Unresolved

Complete Reactive

Refers to transmitted test result:

Transmitted

Empty

User name who validated the test result.

Date of validation.

User name who transmitted the test result to the LIS.

Date and time of transmission.

Time from sample loading on the pooling instrument until final result generation.

For IDT samples that are loaded directly on the analytic system, the

Processing duration

displays the time from sample barcode reading on the analytic system until release of the result to the

cobas Synergy

software.



Panel


> Targets for sample

Sample history

o o

Column

o

Target

o

Flags

o

Interpretation

o

TiterCutoff

TiterValue

o

Analysis Datetime

o

Sample ID

o

Pooling run ID

Pooling status

o

Test

o

Sample type

o

Pipetting volume [ μ L]

o

Test status

o

Overall result

o

Overall result flags

o

Negative control batch ID

o

Rack

o

Position

o

Aliquot plate ID

o

Comment

Comments

Target in test settings.

Information about the flag codes are provided in the

cobas

®

6800/8800 Systems User Assistance.

Target plus result (displayed as “Target:Result”).

Configurable setting for quantitative results: Values are pre-configured, but can be changed if required

(requires sufficient user rights).

Number provided by the analytic system that indicates the viral load.

Date and time of the test.



Current status:

Pending

Complete

Processing

Same for details view for all pooling stages.

Test to be performed on the sample.

Type of sample for the test.

Volume of sample for the test.

Refers to test result:

Complete

Empty

Final result for test ordered for a sample ID. Entries with the same ID and different tests are possible.


cobas

®


Negative control batch ID provided by analytic system.

Carrier ID.

Position of sample in the rack.

Barcode of aliquot plate.

Any comment part of the result file is included in this field.

y



Operation

151

Panel

Sample history > Sample

ID

Column

o

Pool ID

o

Barcode

o

Pooling status

o

Repeat pool

o

Pooling run ID

o


o

Run settings


ID > Target Results

o

Reasons for rejection

o

Target

o

Result

o

Analysis date/time

o

Flags


ID > Reasons for rejection

o

Time stamp

o

Action type

o

Tube ID

o

Pooling run ID

Aliquot plates

o

Comment

o

User

o

Aliquot plate ID

o


y


Comments

Generic number of the database.

Tube barcode.

Pending

Complete

Invalid

True

False


Pooling instrument ID.

Includes pool type, pool size, and test: e.g.

PP6_MPX

or

IDT_MPX

.

Comment entered when the pool was rejected.

Target in test settings.

NR

: Non-reactive

Reactive

Complete Unresolved


Date and time the sample was analyzed.


cobas

®


Date and time the pool was rejected.

Action plus test (displayed as “Reject result Test”).

Pool ID or Sample ID.


Comment entered when the pool was rejected.

User name who rejected the pool.

Aliquot plate identifier (barcode).

Name of the pooling instrument.

q

Fields can be searched and exported to a

.PDF

file.



Evaluating pending pools

Overview

About creating reports

About rejecting pooling runs

About change requests

This section describes options for evaluating and handling pending pools.

After sample IDs are identified for pooling in a pooling order, the sample tubes are checked for validity.

Following this control, they are displayed in the

Pending pools

table.

Samples listed in the

Pending pools

table are meant to be tested as a pool and do not have a final result yet.

Samples may have a pooling history (repeat pooling, resolution pooling, masked pools) or not (primary pools).

For an overview of samples with a pooling history, refer to the Samples to reload report and the Results to pooling run ID report.

u


Reports can be created on the current data displayed on the

Pending pools

panel. The created report can be printed or exported as Excel, PDF, or Word formats.

u


If a hardware failure has occurred or if a pool has become stuck within the data manager, it may be necessary to reject a pooling run. Rejecting the pooling run allows the data manager to set back the sample from

Processing

status to

Pending

status.

Pending pools can be changed in the following ways:

• Pools of 96 can be changed to pools of 6.

• Pools of 24 can be changed to pools of 6.

• Pools of 6 can be changed to IDT.

q

When a pool of 6 is change requested to IDT, the data manager automatically transfers the samples to the

Pending tests

panel.

Change requests can only be performed on pending pools in

Pending

status. Change requests require an electronic signature and are included in the audit trail.

u

Changing pooling orders for secondary and repeat pools (167)


Operation

153

1

r

To evaluate pending pools

1

In the data manager, choose

Routine > Pending pools

.

2

2

To create a report of pending pools, choose the

Create report

button at the bottom left of the table.

3

You can reject a pooling run for which the pooling order is obsolete or recover a pool which has become stuck in

Processing

status. To reject a pool, perform the following steps:

• In the list of pending pools, choose the pool to be rejected.

• Choose the

Reject pooling run

button.

4

To change the pool size of a pool order, perform the following steps:

• In the list of pending pools, choose the samples to be changed.

• Choose the

Change request

button.

• Confirm the change request with your user name and password.



Evaluating pending tests

Overview

About rejecting a pool

About forcing unresolved results

About masking a test order

This section describes options for evaluating and handling all incomplete test orders on the defined analytic systems.

Pending tests view lists samples or pools that are pending for a test. These can be first, secondary or repeat tests.

The following actions can be performed on pending tests:

• Reject pool

• Force unresolved result

• Mask

• Recover test order

• Create report q

Repeat tests should be triggered using the data manager and not the analytic system.

Rejecting a pool sets the pools for the selected test orders to

Invalid

status. A repeat pool order is created with the same size, test, and protocol as for the rejected pool.

Pools can be rejected if a pool is lost, clotted, or if a serology positive result is identified following pool creation. Any pending test orders for a rejected pool are deleted.

If a sample is no longer testable, a result for any remaining tests for the sample is forced and the result is set to complete unresolved. If a sample previously had a reactive target result when tested as IDT, the result is set to complete reactive.

An IDT sample having a high B19 titer (>1.0E+6 IU/mL) in combination with an invalid result needs to be forced unresolved. In this case, the final result is complete reactive.

For an overview of the pooling run history of samples with a high B19 titer, refer to the Invalid DPX pool results report.

u


u


B19 titer (171)

You mask a test order when the pool from which the order originates does not have sufficient volume to complete all required tests.


Operation

155

About recovering a test order


After a pooling run, pools with less samples then the minimum pool size are displayed in bold on the

Pending tests

panel of the

Routine

tab. This indicates that the intended number of tests is not possible. Therefore, if more than one test is configured, masking of tests is necessary.

Masked test orders are treated the same as test orders with an invalid result: The pool is invalid for a test order and is repeated with the secondary run settings.

Only test orders in

Pending

status can be masked. If any test orders with

Processing

status are selected for masking, an error message is displayed. The action does not take place.

To find the pools that need masking, create the Pooling run status report.

Use the


setting to define the minimal number of samples for each pool size.

u


u

Instrument titer cutoff (IU/mL) and Minimum pool size y

(274)

u

Minimum pool size y

(274)

When a crash occurs on the analytic system, follow the instructions in the

cobas

®

6800/8800 Systems User

Guide to resolve the crash on the analytic system.

• Sample tubes and pool tubes with the status

Processing

before the crash on the analytic system generate an invalid result which can be released from the analytic system to the data manager following the normal workflow for invalid results.

• Sample tubes and pool tubes with the status

Scheduled

before the crash on the analytic system remain with the status Scheduled and cannot be reloaded on the analytic system. These samples need to be re-pooled.

To re-pool the samples, use the

Recover test order

button on the

Pending tests

panel of the

Routine

tab in the data manager to change the status of the test order from

Processing

to

Pending

and subsequently reject the test orders. This procedure invalidates the samples and allows to re-pool them.


Pending tests


u




1

r

To evaluate pending tests

1


Routine > Pending tests

.

2

2

To reject the pools for a test, perform the following steps:

• In the list of pending tests, choose the pools to be rejected.

• Choose the

Reject pools

button.

• In the

Request confirmation

dialog box, enter a comment, user name, and password. Choose the

OK

button.

I

This action is included in the audit trail.

3

To mask a pool, perform the following steps:

• Pools that need masking are displayed in bold.

Alternatively, create the Pooling run status report

as described in ( u

178).

• In the list of pending tests, choose the pools to be masked.

• Choose the

Mask

button.

• In the



OK

button.

I


4

To force an unresolved result, perform the following steps:

• In the list of pending tests, choose the samples to be forced unresolved (only pending test orders for individual donor tests can be forced to unresolved).

• Choose the

Force unresolved result

button.

• In the



OK

button.

I



Operation

157

5

To recover a test order, perform the following steps:

• In the list of pending tests, choose the pools to be recovered. Pools to be recovered are in

Processing

status or

In progress

status.

• Choose the


button.

• In the



OK

button.

I


6

To create a report of pending tests, choose the

Create report

button at the bottom right of the table.

7

To view the next 1000 records in the database, choose the

Show next records

button.

Evaluating results for review

Overview

The


panel displays test results. This section describes options for evaluating and handling test results.

By default, the


panel displays all available test results received from the analytic system and ready to be released to the LIS by an authorized user.

Available results include reactive results from pools, invalid results from pools, non-reactive results from pools, or any result from individual donor tests.

If selected, the


panel also displays the already released test results.

The following actions can be performed on the


panel:

• Validate test result

• Reject test result

• Release test result

• Resend already released test result

• Create report q

Final B19 and DPX test results are only available in the data manager, and not on the analytic system.

u

Final B19 and DPX test results (135)

For an overview of final results including validation details, refer to the Donor results report.

u




About validating test results

About rejecting test results

About releasing test results

About resending released test results


Only complete results can be validated, there may not be outstanding tests to complete. Complete results include the following:

• Non-reactive, valid results for pools

• Forced unresolved, invalid results for samples (IDT)

• Non-reactive, valid results for samples (IDT)

• Reactive, valid results for samples (IDT)

When results are validated, they are flagged as validated together with user name and date. The records are ready then for export to the LIS.

Rejecting a test result sets the selected test to

Invalid

status. Only operators with sufficient access rights are permitted to reject test results.

If the selected test results include any reactive results, the action is canceled. When a test result is rejected, a new pending pool order is created.

If all selected records have been validated, they are released to the LIS. Only operators with sufficient access rights are permitted to release test results.

If not all records have been validated, it is not possible to release the test results and an error message is displayed.

If the LIS does not receive test results upon first release, they can be resent. Only operators with sufficient access rights are permitted to resend released test results.




u


1

r

To evaluate results for review

1


Routine > Results for review

.

I

The


panel displays test results.


Operation

159

2

8

2

To validate a test result, perform the following steps:

• In the list of test results, choose the results to be validated.

• Choose the

Validate

button.

3

To reject a test result, perform the following steps:

• In the list of test results, choose the results to be rejected.

• Choose the

Reject

button.

• In the



OK

button.

4

To release test results to the LIS, perform the following steps:

• In the list of test results, choose the results to be released.

• Choose the

Release

button.

5

To save the test results information as a

.CSV

file, choose the

Export

button.

6

To create a report of test results, choose the

Create report


7



button.

8

To resend already released test results to the LIS, perform the following steps:

• Above the list of test results, select the

Include transmitted results

check box.

• Optionally, to find the test results you want to resend, sort and/or filter the list as described in

( u

86). For example, display only test results that

were released during a specific time interval.

• In the list of test results, choose the results to be resend.

• Choose the

Release

button.



Evaluating sample history

1

This section describes options for viewing and commenting of all unreleased samples.

r

To evaluate sample history

1


Routine > Sample history

.

2

2

To view sample information, in the

Sample history

table, choose the sample. q

The

Sample history

table includes pool run ID information. Only consider IDs coming from the initial primary or secondary pool run.

3

3

Additional sample information is provided in the

Pools

table, the

Target Results

table, and the

Reasons for rejection

table.


Operation

161

4

4

To assign a comment to a sample, do the following actions:

• Choose the

Add comment

button.

• Enter your comment.

• Choose the

OK

button.

I

Assigning comments can depend on your access rights. You can assign comments to more than 1 sample at a time.

5



button.

6

To view rejection reason and result flag information, choose the sample in the


table and create a report.



Evaluating aliquot plates

1

This section describes options for evaluating aliquot plates.

r

To evaluate aliquot plates

1


Routine > Aliquot plates

.

2

2

In the list of aliquot plates, choose the plate to be viewed.

I The list can be sorted by "Barcode" or by "Sample barcode".

3

3

The wells of the aliquot plates are displayed with information about their status (filled, error, excluded, or empty).

4

To print the aliquot plate information, choose the

Print

button.

5

To save the aliquot plate information as a

PDF

or

CSV

file, choose the

Export

button.

u

Related topics

• Reporting in the data manager (174)


Operation

163

Handling a pool when not all samples were confirmed

If the number of samples loaded for a pool type is too many or too few you can ignore the additional samples or cancel the run.

If the number of samples loaded for a pool type is too many or too few, the following message is displayed in the pooling instrument manager: w

Unconfirmed sample tubes

In this case, there are 2 ways to handle unconfirmed samples in a pool type:

• The preferred solution is to ignore the additional samples and continue with the pool. You can then create a pool with the remaining samples.

• Alternatively, you can cancel the pooling run and create a new pooling run with the correct number of samples.

u

To ignore samples p

(164)

To cancel the run p

(164)



1

r

To ignore samples

1

In the pooling instrument manager, in the dialog box, choose the

Ignore

button.

2

2

In the


table, additional loaded sample tubes have

Unconfirmed

status and are not pipetted.

3

Continue creating the pool.

4

4

After the run has completed, remove the unconfirmed samples from the instrument deck.

• The unconfirmed samples can be included in a new pool.

I

The data manager indicates the location of the unconfirmed samples.

1

r

To cancel the run

1

In the pooling instrument manager, in the dialog box, choose the

Cancel

button.

2

2

To unload the sample carriers automatically, in the dialog box, choose the

Yes

button.

3

Remove the surplus samples from the autoload tray.

4

Restart the pooling run with the same run settings as previously.

u

Related topics



Operation

165

Handling invalid pools

Overview

This section provides information on how to identify and handle invalid pools.

Pipetting errors and other issues during the pooling process can result in a sample not being included in a pool. If samples are not included in the pool, an invalid pool can result. For this reason, it is important to confirm if a pool can be loaded onto the analytic system.

Invalid pools can be identified in the following locations:

• In the data manager in the messages panel

• In the data manager in the Pooling run status report q

To minimize potential risks during the analytic system run, always confirm if a pool is included in the list of pending tests following the pooling process.

1

3

r

To handle invalid pools

1

Immediately following the pooling run, in the pooling instrument manager in the

Pipetting

panel, any sample which was not pipetted correctly is highlighted.

2

The view additional information about the pipetting status, choose the highlighted sample. f

The

Sample tube

panel is displayed.

3

If a problem has occurred during pipetting, in the data manager message panel, choose the

Warnings

tab. If the issue during pipetting has resulted in an invalid pool, it is listed here.

4

For further information, create the Pooling run status report in the data manager for invalid pools of a specific pooling run.



5

6

5

Invalid pools are not listed in the

Pending tests

table and cannot be loaded onto the analytic system. The only exception is for pools with a pool size between the manually entered value and the defined lower limit for the pool. These pools are displayed with bold highlighting in the

Pending tests

table, and can be loaded onto the analytic system.

q

To ensure error-free processing on the analytic system when running such a pool, mask one or more of the test orders.

u

About masking a test order (154)

6

All remaining pools listed as invalid in the data manager message panel include samples requiring a repeat pool. To view the samples in an invalid pool, choose


. Select the

Include invalid pooling orders

option.

7

Create the Samples to reload report to identify the samples that have to be reloaded onto the pooling instrument.

u

Related topics

• Evaluating pending tests (154)


Operation

167

Changing pooling orders for secondary and repeat pools

You can manually change the pooling order, when appropriate, using the

Change request

button.

The change request function changes a pool of 96 or a pool of 24 to a secondary pool of 6, and a pool of 6 to an

IDT.

1

r

To change a pooling order for a secondary and repeat pool

1



. Search for the sample you want to change the pooling order for.

2

2

To change the pooling order, select the sample and choose the

Change request

button.

f

The


dialog box is displayed.



3

3

To confirm the change request, enter the

Comment

field, the

User name

field, and the

Password

field.

Choose the

OK

button.

u

Related topics

• Creating secondary and repeat pools (168)

Creating secondary and repeat pools

Overview

Reports

Reactive and invalid pool results require further testing.

The procedures for running secondary and repeat pools are identical.

If a secondary or repeat pool is required, the system adds the pool to the

Pending pools

table in the data manager.

Reactive primary or secondary pools of 6 are sent directly to the

Pending tests

list for IDT testing; no pooling is performed.

The following

cobas Synergy

reports help you to identify samples requiring secondary or repeat pooling:

• Pooling run status report

• Results to pooling run ID report

• Samples to reload report u


1

r

To create secondary and repeat pools

1



.


Operation

169

2

2

In the

Pending pools

list, identify the samples requiring secondary or repeat pooling.

3

3

To create the pool, perform the following steps:

• In the pooling instrument manager, choose

Routine > Start run - Select run settings

.

• Create a pool of the samples using the run settings from the

Pending pools

list.

• Follow the procedure for creating a pool: ( u

136).

Repeat testing on the analytic system after an invalid test result

Overview

Pools with an invalid test result require further action, e.g., repeat testing on the analytic system.

After an invalid result for a pool tube is released from the analytic system to the data manager, new pooling orders with the same pool size are created for the samples within the invalid pool.

If enough volume for repeat testing is left in the pool tube, the user can repeat the test with the original pool tube instead of performing a new pooling run.



6

r

To repeat tests on the analytic system after an invalid test result

1

On the analytic system, go to

Routine > Control batch

or

Routine > Test results

and check for invalid results.

2

If there are invalid results, select them and create a report:

• From the printer drop-down list on the right, choose the

Preview

option to create a report preview of the selected results.

• Alternatively, from the printer drop-down list on the right, choose the

Print

option to print out the selected results.

3

NOTICE Do not release valid results of a multi-test order as this prevents repeat testing.

3 To release the results from the analytic system to the data manager, do the following:

• For a single test order (e.g. PP96_MPX), select the invalid result and choose the

Release

button.

• For a multi-test order (e.g. PP96_DPX_MPX) with a valid result for one test (e.g. DPX) and an invalid result for the other test (e.g. MPX), select the invalid result only and choose the

Release

button.

4

With the pool tube information from the report above, search for the pool tubes that have an invalid test result and physically check them if there is sufficient volume, no foam, and no clots.

5

If the original pool tube is OK, reload it on the analytic system.

f

In the data manager, a repeat test order is created.

6


Routine > Pending tests

. With the pool tube information from the report above, check the repeat test order:

• If a single pool tube was reloaded, filter the

Tube

ID

column for the original pool tube ID.

The pool is in

Processing

status and has a

Repeat pool

source.

• If an IDT was reloaded, it has a

Repeat IDT

source.

• If more than one pool tube was reloaded, filter the

Source

column for “Repeat”. All reloaded pool tubes are displayed.


Operation

171

Handling invalid HAV results due to samples with high

B19 titer

The DPX test simultaneously quantifies B19V DNA and detects HAV RNA.

Samples with a high B19 titer (>1.00e+006 IU/mL) can cause invalid HAV results forcing the overall result to become invalid (for more information refer to the Method

Sheet of the DPX test). q

Only the DPX test is affected, but not the DPX-B19 test.

The analytic systems sends the B19 titer to the data manger allowing an invalid DPX pool due to samples with high B19 titer to be recognized as reactive. An invalid

DPX result with a high B19 titer and an invalid HAV result is resolved with an SP6 order or an IDT resolution order.

At the end of the resolution workflow of a DPX result with a high B19 titer, the DPX IDT result has to be manually forced to the


status in the


panel.

Result from

Pool

Pool

IDT

IDT

Overall result B19 titer

Invalid

Invalid

Invalid

Invalid

1.00e+006 IU/mL to 1.00e+009 IU/mL

>1.00e+009 IU/mL (above linear range)

1.00e+006 IU/mL to 1.00e+009 IU/mL

>1.00e+009 IU/mL (above linear range) y

B19 high titer workflows on

cobas

®

6800/8800 Systems V1.2.13

Workflow Outcome

Automatic resolution

(no manual intervention is required)

Automatic resolution

(no manual intervention is required)

In


panel, manually force result to be unresolved.

In


panel, manually force result to be unresolved.





1

2

3

r

To force an invalid HAV result to be unresolved for an IDT sample

1

To release the results from the analytic system to the data manager, select the sample IDs with invalid HAV result and high B19 titer result (>1.00e+006 IU/mL) and choose the

Release

button.

I

In case of IDT samples, the sample ID on the analytic system is the ID of the original sample tube (no pooling is done for IDT samples).

2


Routine > Results for review

.

• Filter the

Test

column for DPX tests.

• Filter the

Overall result

column for

Invalid

overall results.

• Sort the

Titer value

column to list the invalid DPX tests with a high B19 titer result on top of the list.

3

Select the DPX tests that have a high B19 titer result

(>1.00e+006 IU/mL) and check the details of the result. For all DPX tests with a high B19 titer result and an

Invalid

HAV result, choose the


button, and confirm this action.

f

All selected results are set to


.


Operation

173

Searching samples

1

To search for a sample in the

cobas Synergy

solution, use the Where is my sample report.

r

To search for a sample

1


Reports > cobas

Synergy report settings

.

2

2

Choose the Where is my sample entry. At the bottom right of the table, choose the

Create report

button.

f

The query dialog box is displayed.

3

3

Enter the sample ID at the top of the query dialog box.

Where Is My Sample Report

Roche Molecular Systems

4300 Hacienda Drive

Pleasanton, CA 94588

Query Conditions

Sample ID :

I54I3PWX

Last known position of the sample on pre-analytic or pooler instrument :

Rack ID :

9GFCKGP9

Position in rack :

1

Sample was used on following pooler instruments :

Pooler instrument :

Pooler instrument :

1001

1001

Pooling run ID :

Pooling run ID :

1152

1157

Sample was seen on following analyzer instruments :

Instrument :

1001

Date and time :

10/7/2016 2:53 PM

Pool tube loaded on :

10/7/2016 2:52 PM

Pool tube loaded on :

10/7/2016 2:53 PM

Analyzer instrument :

Analyzer instrument :

006667

006667

Result created on :

10/7/2016 2:53 PM

Result created on :

10/7/2016 2:53 PM

4

Report created on 11/9/2016 12:13 PM by Sanguin Where Is My Sample Report cobas Synergy v. 1.1.14

Page 1 of 1

4

Chose the

View Report

button.

f

The report is displayed with information about the last known position and on which pooling instruments and analytic systems the sample was used or seen.


174 Reporting in the data manager

Reporting in the data manager

The data manager includes reports for operation, information, monitoring, and troubleshooting purposes.

In this section

Report types (174)


Handling reports (179)

Report types

Panel reports cobas Synergy reports

Reports in the data manager differ in content, calling sequence, degree of customization, and purpose.

The data manager includes the following report types:

• Panel reports (pending pools, pending tests, and results for review)

•

cobas Synergy

reports

• Aliquot plate report

• Audit trail report

• Problem report

• Aurora reports (legacy functionality)

Routine > Pending pools > Create report

Routine > Pending tests > Create report

Routine > Results for review > Create report

Panel reports contain the data currently displayed in the

Pending pools

panel, the

Pending tests

panel, or the


panel.

u

Evaluating pending pools (152)

u

Evaluating pending tests (154)

u


u


Reports > cobas Synergy report settings > Create report cobas Synergy

reports contain data to support routine operation or to monitor solution performance. They are created based on your search criteria.

u


u



Operation

175

Aliquot plate report

Audit trail report

Problem report

Aurora reports

Routine > Aliquot plates > Print

Routine > Aliquot plates > Export

The aliquot plate report contains information about the status of the aliquot plate wells (filled, error, excluded, or empty).

u

Evaluating aliquot plates (162)

System > Manager > View log file > Operator activity

For traceability, an audit trail report includes all activities assigned to the audit trail. u

View operator activity log work area (329)

System > Problem reporter

A problem report contains information about problems with the data manager for Roche service.

u

Creating a problem report in the data manager (234)

Reports > Aurora report settings

The Aurora report runner is a legacy functionality to create reports. This report runner cannot include parts of the information available in the database, and required for reports in

cobas Synergy

solution. It is recommended not to use the Aurora report runner.

cobas Synergy reports

cobas Synergy

reports can be used during routine operation, for solution monitoring, and for troubleshooting purposes.

In this section

Alarm report (176)

Operation reports (176)

Quality reports (177)

Creating a cobas Synergy report (178)



Alarm report

An alarm report is a

cobas Synergy

report for troubleshooting purposes.

The alarm report collects messages from components and functions of the

cobas Synergy

solution that generated the message, for example:

•

Analyzer Manager

(interface to

cobas

®

Systems)

6800/8800

•

Pooling Manager

(interface to pooling instrument manager)

•

System

(data manager) u


Operation reports

Pooling run status report

Samples to reload report

Sample audit report

Invalid DPX pool results report

Results to pooling run ID report

Donor result report

Where is my sample report

Operators, technical supervisors, and laboratory supervisors can use

cobas Synergy

operation reports to support routine operation.

Overview of pool status after pooling, in order to determine follow-up actions for pools (e.g. repeat pooling, test masking) and for filing purposes.

Overview of sample status after pooling, in order to determine follow-up actions for samples (e.g., reload, resolve clots, resolve volume issues).

Overview of the sample history for a specified sample, in order to fully trace what happened to a particular donation.

Overview of the pooling run history for samples with a high B19 titer (i.e. invalid HAV results), in order to set the samples to complete unresolved status.

Overview of the pooling run history for samples with reactive or invalid test results, in order to find sample tubes for creation of secondary pools.

Overview of final results including validation details for filing purposes.

Overview of processing stages and last known position of a sample in the pooling and testing workflow in order to find a sample.


Operation

177

Quality reports

Donor summary report

Initial reactive pools report

Testing summary report

Invalid test results report

Pooler performance report

Pooler performance export report

Laboratory supervisors can use

cobas Synergy

quality reports for performance monitoring, e.g. to see trends and upcoming problems early for investigation.

Overview of the test results for each received donation.

Overview of initially reactive pools with non-reactive resolution pools.

Overview of testing performance over a period of time and over several pooling instruments and tests. The report allows trending, workload optimization, and early recognition of maintenance needs. It includes the number of reactive targets.

Overview of invalid test results in order to see trends.

Overview of pooling performance over a period of time and over several pooling instruments. The report allows trending, workload optimization, and early recognition of maintenance needs. It includes the type and number of valid pools created.

This report is the same as the Pooler performance report, but it has a special format for data export supporting further data analysis.



Creating a cobas Synergy report

1

This section describes how to create

cobas Synergy

reports, including alarm reports.

To create a

cobas Synergy

report, choose the report and then specify the search criteria.

r

To create a cobas Synergy report

1


Reports > cobas

Synergy report settings

.

2

2

To create a report, in the list of reports, choose the corresponding entry. At the bottom right of the table, choose the

Create report

button.

I

Do not try to create subreports (all list entries starting with “zz_subreport”).

f

A new dialog box is displayed.

3

3

Enter the search criteria at the top of the dialog box.

4

Chose the

View Report

button.

f

The report is displayed, which offers options for handling reports.

u

Related topics

• Handling reports (179)


Handling reports

Operation

179

Panel reports and

cobas Synergy

reports are displayed in a report window.

The report window offers options for report handling.

w

Report window

2

r

To handle reports

1

Create a panel report or a

cobas Synergy

report.

f

The report window is displayed.

2

At the top of the report window is a menu bar with commands for handling the report.

3

To navigate through the report, at the left-hand side of the menu bar, enter the page number to go to or scroll forwards or backwards using the buttons

4

To return to the parent report, choose the button.

5

To stop rendering the report, choose the button.

6

To refresh the report data, choose the button.

7

To print the report, choose the button.

8

To change the print layout, choose the button.




After operation

Table of contents

181

10

In this chapter

10

Shutting down the system. . . . . . . . . . . . . . . . . . . . . . . 183

Shutting down the system. . . . . . . . . . . . . . . . . . . . 183

Restarting the system. . . . . . . . . . . . . . . . . . . . . . . . 185


182

Table of contents


After operation

183

Shutting down the system

Shutting down the system

Follow this procedure to shut down the system. Exit the data manager, shut down the workstation, exit the pooling instrument manager, shut down the control unit, and switch off the instrument.

q

Even though the software schedules daily maintenance before operation, Roche recommends the following checks before shutdown: o

Make sure that the solid waste bag is empty.

o

Make sure that the instrument surface and the carriers are clean.

NOTICE

Risk of software damage due to incorrect shutdown

Turning off the computer may damage

cobas Synergy

software components and cause the software to function improperly when the application is restarted.

r

Only use the normal Microsoft Windows power-off procedure.

c

• When you do not plan to use the system, for example, overnight.

n

• 5 minutes j m

No pooling run is active.

m All supplies are unloaded.


184 Shutting down the system

1

r

To shut down the system

1

In the data manager, expand the

System

menu.

2

Choose the

Exit

command.

3

3

To exit the data manager, choose the

Yes

button. To remain logged on, choose the

No

button.

4

To shut down the data manager workstation, use the

Windows shut down command.

5

5

To switch off the instrument, press the power switch.

6

To close the pooling instrument manager, choose the close button at the top right of the main work area or press Alt+F4.

7

To shut down the pooling instrument control unit, use the Windows shut down command.


After operation

185

Restarting the system

In some error cases, a manual restart is required.

If a restart is required, perform the following actions: q

If a hardware error has occurred, be sure to perform daily maintenance.

u

Shutting down the system (183)

u


r

To restart the system

1

Perform a system shutdown. ( u

183)

2

Start up the system. ( u

121)

3

If a hardware error has occurred, perform daily maintenance.


186 Shutting down the system


Maintenance

Table of contents

187

11

In this chapter

11

Maintenance intervals . . . . . . . . . . . . . . . . . . . . . . . . . . 189

Periodic maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 190

About periodic maintenance. . . . . . . . . . . . . . . . . . 190

Performing daily maintenance . . . . . . . . . . . . . . . . 191

Performing weekly maintenance . . . . . . . . . . . . . . 195

Verification procedures . . . . . . . . . . . . . . . . . . . . . . 200

Regular maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . 201

Cleaning the outside of the instrument . . . . . . . . . 201

Decontamination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202

General decontamination procedure . . . . . . . . . . . 202

Decontaminating the Microlab

®

STAR IVD. . . . . . 205


188

Table of contents


Maintenance

189

Maintenance intervals

Periodic maintenance

Preventive maintenance

Periodic maintenance actions ensure safe and reliable operation of the system.

Periodic maintenance is mandatory. Daily and weekly maintenance actions must be performed to operate the system.

Preventive maintenance is carried out by your Roche



190 Periodic maintenance

Periodic maintenance

This section describes periodic maintenance actions to be performed with the Microlab

®

STAR IVD.

In this section

About periodic maintenance (190)


Performing weekly maintenance (195)

Verification procedures (200)

About periodic maintenance

The

cobas Synergy

core requires periodic maintenance.

The pooling instrument manager software includes wizards to guide you through the maintenance actions.

q

A run cannot proceed unless all maintenance is up to date. Always use the wizard to perform maintenance actions so that service counters are reset. Always follow good laboratory practice when using the

cobas Synergy

solution.

General cleaning

The area around each instrument should be periodically checked to ensure that air flow is unrestricted and that books, papers, or other supplies are not interfering with air flow.

If a sample or other biohazardous material spills on any instrument or any of the carriers, the area or carriers should be cleaned with a decontamination solution, followed by deionized water.


A

Maintenance

191

Required maintenance

Periodic maintenance for the instrument is listed at the bottom of the

Routine

panel. Required maintenance is highlighted by a red marker in this list.

B

C

A Routine

panel

B Maintenance

group box w Location of maintenance actions on pooling instrument manager

C Perform maintenance

button

Performing daily maintenance

The section describes how to perform daily maintenance actions.

u

Quick reference: Daily maintenance y

(212)

NOTICE

Use of disinfectants.

Incorrectly using disinfectants can result in damage to the instrument.

r

Use disinfectant solutions recommended by Roche

Service.

r

Use cleaning and disinfectant solutions in accordance with manufacturer's instructions.

r

Do not use disinfectants that contain hypochlorite or bleach.



About the waste unit

A

B

C

D

A

Support frame w

Parts of the waste unit

B

Initialization/waste block

C

Tip eject plate c

Daily d m Solid waste bag m

Powder-free lab gloves m Eye protection m

Lab coat m Disinfectant

D

Solid waste bag or waste chute

2

r

To start daily maintenance

1

Start the pooling instrument manager.

2

Required maintenance is highlighted by a red marker in the list of maintenance actions. To start daily maintenance, in the

Maintenance

group box, choose the

Perform maintenance

button.

f The pooling instrument manager closes.

f

The

Hamilton Maintenance and Verification

Run



Maintenance

193

3

3

From the list of maintenance actions, in the

Execute

column, select the

Daily maintenance

check box.

4

On the command menu, choose the icon.

f

The pipetting arm and the autoloader move to the left hand side. f

The Hamilton Run Control

work area and

Daily maintenance - check deck cleaning

dialog box are displayed.

1

r

To check the instrument deck

1

Open the front cover of the instrument.

2

2

Inspect all parts of the instrument and carriers.

3

3

If the instrument deck requires cleaning, on the


dialog box, choose the

Cancel

button and perform weekly

maintenance: ( u

195).

4

If the instrument deck is clean, on the



OK

button and continue with daily maintenance.



1

3

4

r

To empty tip waste and clean the tip eject plate

1

CAUTION! Infection by biohazardous waste.


1 To remove the full solid waste bag, remove the support frame from the initialization/waste block.

2


Always consider the tip waste, the tip eject plate, and the waste chute as biohazardous.

2 Dispose of the solid waste bag in accordance with local regulations.

3

To replace the solid waste bag, put the bottom part of the bag inside the support frame, fold the top over the frame and then place the support frame into the initialization/waste block.

I

If the instrument is installed on a special trolley, a waste chute can be used to direct used tips into a solid waste bag. It is recommended to replace the waste chute on a weekly basis or as required.

Follow the instructions above to replace the waste chute.

4



4 Remove the tip eject plate and clean it with disinfectant solution. Put the clean tip eject plate back in place.

5

5

WARNING! Personal injury due to contact with moving parts.

Stay clear of the pipetting arm as it moves to the right hand side to pick up the teaching needles.

The pipetting arm and the autoloader move to the right hand side.

5 On the

Daily maintenance- tip waste


OK

button.

• The system performs an over-pressure and underpressure check of the pipetting channels.

• The system then performs a capacitive liquid level detection check.

I

If the automatic tightness or liquid level detection checks fail, repeat the procedure twice, then contact Roche Service.


Maintenance

195

6

6

On the

Daily maintenance - successful


OK

button.

Performing weekly maintenance

The section describes how to perform weekly maintenance actions.

u

Quick reference: Weekly maintenance y

(213)

q

Daily maintenance does not need to be performed if weekly maintenance is performed.

NOTICE

Use of disinfectants.

Incorrectly using disinfectants can result in damage to the instrument.

r

Use disinfectant solutions recommended by Roche

Service.

r

Use cleaning and disinfectant solutions in accordance with manufacturer's instructions.

r

Do not use disinfectants that contain hypochlorite or bleach.

c

Weekly d m

Solid waste bag m

Powder-free lab gloves m

Eye protection m

Lab coat m

Paper towels m

Lint-free cloths or cotton swabs m

Ethanol (70%) m

Disinfectant



2

3

r

To start weekly maintenance

1

Start the pooling instrument manager.

2

Required maintenance is highlighted by a red marker in the list of maintenance actions. To start weekly maintenance, in the

Maintenance

group box, choose the


button.

f

The pooling instrument manager closes.

f

The

Hamilton Maintenance and Verification

Run


3

From the list of maintenance actions, in the

Execute

column, select the

Weekly maintenance

check box.

4

On the command menu, choose the button.

f

The instrument initializes and the instrument deck is unloaded automatically, f

The Hamilton Run Control

window and

Weekly maintenance - check autoload tray

dialog box are displayed.

1

2

r

To remove and clean the carriers

1


Stay clear of the pipetting arm as it moves to the right to pick up the teaching needles.

1 Remove all carriers from the autoload tray. On the

Weekly maintenance - check autoload tray


OK

button.

• The system performs an over-pressure and underpressure check of the pipetting channels.

• The system then performs a capacitive liquid level detection check.

I

If the automatic tightness or liquid level detection checks fail, repeat the procedure twice, then contact Roche Service.

2

NOTICE Carriers must be completely clean and dry before re-using.

2 Clean all carriers with disinfectant and allow them to dry.


Maintenance

197

1

r

To clean the instrument deck

1

Open the front cover and wipe the instrument deck with a lint-free cloth saturated with disinfectant solution.

The slide blocks (the guides on the autoload tray for proper insertion of the carriers) in particular must be checked for cleanliness.

2

2


Stay clear of the pipetting arm and the autoloader as they move to the left hand side of the instrument.

2 On the

Weekly maintenance - deck cleaning


OK

button.

1

r

To empty tip waste

1



1 To remove the full solid waste bag, remove the support frame from the initialization/waste block.

2



2 Dispose of the solid waste bag in accordance with local regulations.



3

3

To replace the solid waste bag, put the bottom part of the bag inside the support frame, fold the top over the frame and then place the support frame into the initialization/waste block.

I

If the instrument is installed on a special trolley, a waste chute can be used to direct used tips into a solid waste bag. It is recommended to replace the waste chute on a weekly basis or as required.

Follow the instructions above to replace the waste chute.

1

r

To clean the tip eject plate, the laser scanner window, the instrument covers, and the autoload protecting ribbon

1



1 Remove the tip eject plate and clean it with disinfectant solution. Put the clean tip eject plate back in place.

2

2

Check the laser scanner window for the barcode reader on the autoloader and clean it with a lint-free cloth or cotton swab lightly soaked in ethanol (70%).

I

The laser scanner window must be completely dry and free from dust and fibers before the Microlab

®

STAR IVD can be reused.


Maintenance

199

3

3

Clean the front and side covers of the instrument with a lint-free cloth soaked in disinfectant solution and wipe dry.

4

4

Clean the autoload protecting ribbon with a lint-free cloth soaked in disinfectant solution and wipe without exerting pressure.

5

5


Stay clear of the pipetting arm and autoloader as they move to the right hand side of the instrument.

5 On the

Weekly maintenance - tip waste


OK

button.

6

6

On the

Weekly maintenance - successful


OK

button.



Verification procedures

This section describes instrument verification procedures.

The Microlab

®

STAR IVD is verified by Roche Service representatives upon initial set-up, and thereafter at regular intervals.

If any verification procedures are due and have not been successfully completed, the Microlab

®

STAR IVD will not run any pool.

The following instrument functions are verified by Roche

Service representatives:

• accuracy and precision of dispensing (volume verification)

• barcode reading

• calibration of vertical, horizontal, and lateral position q

A warning dialog box will display giving 10 days notice of any required verification procedures.


Maintenance

201

Regular maintenance

In this section

Cleaning the outside of the instrument (201)

Cleaning the outside of the instrument

The outside of the instrument must be cleaned regularly.

c

As required d m

Lab gloves m

Lab coat m

Eye protection m

Lint-free cloth m

70% ethanol p.a.

m

Deionized water r

To clean the outside of the instrument

1

Clean the instrument covers and autoload tray with a lint-free cloth moistened with deionized water.

2

Repeat the cleaning procedure using a lint-free cloth moistened with 70% ethanol.


202 Decontamination

Decontamination

In this section

General decontamination procedure (202)

Decontaminating the Microlab

®

STAR IVD (205)

General decontamination procedure

In certain situations, it is necessary to decontaminate the instrument.

To get the best result, it is important to follow the outlined decontamination procedures for DNA AWAY™ Surface

Decontaminant or sodium- or potassium hypochlorite

(0.6%).

NOTICE

Damage to the instrument due to inappropriate use of decontamination solutions

The recommended decontamination solutions are highly corrosive. Excessive use may damage the affected surfaces.

r Exactly follow the outlined decontamination procedures.

r Use only the recommended decontamination solutions.

r Make sure to decontaminate only the contaminated areas.


Maintenance

203

q

Observe the following rules for decontamination: o

Do not use technical or denatured ethanol for preparation of the cleaning solution.

o

Do not spray liquid directly on any part of the instrument.

o

Moisten the lint-free cloth outside the instrument and wipe the surfaces and parts as described in these procedures.

o

Instead of deionized water you can use distilled or otherwise purified water.

o

Take care when applying liquid to the lint-free cloth.

The cloth should be damp, but not saturated to prevent drops of liquid from falling onto the instrument.

o

Before using DNA AWAY™ Surface Decontaminant, read the precautions on the bottle label carefully. For more information or a Maintenance Safety Data Sheet, refer to www.mbpinc.com.

o

Change lab gloves after each cleaning step.

o

Dispose of the material as potentially biohazardous material.

c

When required, for example when sample has contaminated the instrument.

n

Depends on the area to be decontaminated.

d m


Personal protective equipment m

Lint-free cloths m

70% ethanol p.a. or mikrozid

® m

Deionized or distilled water m

Decontamination solution either DNA AWAY™ Surface Decontaminant

(Molecular BioProducts, Inc.) or 0.6% (w/v) freshly prepared sodium- or potassium hypochlorite solution (bleach)



r

To decontaminate using DNA AWAY™

Surface Decontaminant

1

Clean the surfaces and parts with a lint-free cloth moistened with deionized or distilled water.

2

Clean the surfaces and parts with a lint-free cloth moistened with DNA AWAY™ Surface

Decontaminant. Wait for 10 minutes.

3

Clean the surfaces and parts with a lint-free cloth moistened with deionized water. Wait for 10 minutes.

4

Clean the surfaces and parts with a lint-free cloth moistened with DNA AWAY™ Surface

Decontaminant. Wait for 10 minutes.

5


6

Clean the surfaces and parts with a lint-free cloth moistened with 70% ethanol. Wait for 10 minutes.

r

To decontaminate using sodium- or potassium hypochlorite solution

1

Clean the surfaces and parts with a lint-free cloth moistened with deionized or distilled water.

2

Clean the surfaces and parts with a lint-free cloth moistened with sodium- or potassium hypochlorite solution (0.6%). Wait for 10 minutes.

3


4

Clean the surfaces and parts with a lint-free cloth moistened with sodium- or potassium hypochlorite solution (0.6%). Wait for 10 minutes.

5


6

Clean the surfaces and parts with a lint-free cloth moistened with 70% ethanol. Wait for 10 minutes.


Maintenance

205

Decontaminating the Microlab

®

STAR IVD

All carriers and the tip eject plate must be decontaminated regularly.

c

As defined in the standard operating procedure of your laboratory. At least once a week.

d m


Personal protective equipment m

Lint-free cloths m

70% ethanol p.a. or mikrozid

® m

Deionized or distilled water m neodisher

®

MediClean m

Decontamination solution either DNA AWAY™ Surface Decontaminant

(Molecular BioProducts, Inc.) or 0.6% (w/v) freshly prepared sodium- or potassium hypochlorite solution (bleach)

1

r

To decontaminate the Microlab

®

STAR IVD

1

Clean the front and side covers as described in the general decontamination procedure.

2

2

Open the front cover and clean the instrument deck as described in the general decontamination procedure.



3

3

Remove the tip eject plate of the tip waste station and clean it.

4

4

Apply disinfectant to the surface of the tip waste station.

5

5

Clean the outer part of the pipetting channels by wiping with a lint-free cloth soaked with decontamination solution.



Table of contents

207

12

In this chapter

12

Creating a pool . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 208

Preparing aliquot plates. . . . . . . . . . . . . . . . . . . . . . . . . 209

Evaluating pool results. . . . . . . . . . . . . . . . . . . . . . . . . . 210

Daily maintenance on the pooling instrument . . . . . . 212

Weekly maintenance on the pooling instrument . . . . 213


208 Creating a pool

Creating a pool

Steps

1

Log on.

2

Choose the pool type.

Creating a pool includes the following steps:

User action

1. Log on to the pooling instrument manager.

2. Perform any maintenance action that is due.

u

Daily maintenance on the pooling instrument (212)

u

Weekly maintenance on the pooling instrument (213)

1. In the


list, choose the type of pool to be performed.

2. Choose the

Start pooling

button.

3

Log on.

1. When prompted, enter your logon information.

2. Choose the

Log on

button.

4

5

6

Load sample carriers.

Load supplies.

Start pooling run y Quick reference: Creating a pool


1. In the tracks indicated in the

Start

panel, load the sample carriers onto the autoload tray.

2. Choose the


button.

3. After sample loading has been confirmed, choose the


button.

1. Load the tip rack carriers into one of the positions indicated on the

Supplies

panel.

2. Choose the


button.

3. Starting from the left-hand side of the area indicated on the

Supplies

panel, load the pool tube carriers.

4. Choose the

Load pool tubes

button.

1. To start the pooling run, choose the

Pipetting

button.

2. To complete the pooling run and create a pool or aliquoting run, choose the

Start new run

button.


209


Steps

1

Log on.

Preparing aliquot plates includes the following steps:

User action


2. Perform any maintenance action that is due.

u

Daily maintenance on the pooling instrument (212)

u

Weekly maintenance on the pooling instrument (213)

2

Choose the pool type

Aliquoting.

1. In the


list, choose the

Aliquoting

option.

2. Choose the

Start pooling

button.

3

Log on.

1. When prompted, enter your logon information.

2. Choose the

Log on

button.

4

5

6

Load sample carriers.

Load supplies.

Start pooling run y Quick reference: Preparing aliquot plates


1. In the tracks indicated in the

Start

panel, load the sample carriers onto the autoload tray.

2. Choose the


button.

3. After sample loading has been confirmed, choose the


button.

1. Load the tip rack carriers into one of the positions indicated on the

Supplies

panel.

2. Choose the


button

3. Load the aliquot plate carriers into one of the positions indicated on the

Supplies

panel.

4. Choose the

Load aliquot plates

button.

1. To start the run, choose the

Pipetting

button.

2. To complete the aliquoting run and create a pooling or aliquoting run, choose the

Start new run

button.

210 Evaluating pool results

Evaluating pool results

Steps

1

Evaluate pending pools.

2

Evaluate pending tests.

3

Evaluate results for review.

Evaluating the pool results includes the following actions:

User action

1. You can reject a pooling run for which the pooling order is obsolete or recover a pool which has become stuck in

Processing

status. To reject a pooling run, choose the pool to be rejected and choose the

Reject pooling run

button.

2. To change a pool order, choose the pool order to be changed and choose the

Change request

button. Confirm with your user name and password.

1. To reject a pool that has a test order, choose the pool to be rejected. Choose the

Reject pools


2. To force an unresolved result, choose the sample (only IDT pending tests can be force unresolved). Choose the



3. To recover a test order, choose the pools to be recovered. Choose the



4. To create a report of pending tests, choose the

Create report


5. To view the next 1000 records in the database, choose the


button.

The


panel displays test results.

1. To validate a test result, choose the results to be validated. Choose the

Validate

button.

2. To reject a non-reactive test result, choose the results to be rejected. Choose the

Reject


3. To release test results to the LIS, choose the results to be released and choose the

Release

button.

4. To save the test results information as a

.CSV

file, choose the

Export

button.

5. To create a report, choose the

Create report

button.



button.

7. To resend already released test results to the

LIS, select the

Include transmitted

results check box. Choose the results to be resend and choose the

Export

button.

y

Quick reference: Evaluating pool results


Steps

4

Evaluate sample history.

5

Evaluate aliquot plates.

y Quick reference: Evaluating pool results


211

User action

1. Choose a sample.

2. To add a comment, choose the

Add comment

button. Enter your comment.

Choose the

OK

button.



button.

1. Choose the plate to be viewed.

2. To print the aliquot plate information, choose the

Print

button.

3. To save the aliquot plate information as a

PDF

file, choose the

Export

button.


212 Daily maintenance on the pooling instrument

Daily maintenance on the pooling instrument

Steps

1

Log on.

The daily maintenance on the pooling instrument includes the following steps:

User action


2

Start daily maintenance.

3

Check that instrument deck is clean.

4

Empty the tip waste and clean the tip eject plate.

5

Check tightness of pipetting channels.

6

Verify proper function of liquid level detection y

Quick reference: Daily maintenance

1. In the

Maintenance

group box of the pooling instrument manager, choose the


button.

2. From the list of maintenance actions, in the

Execute

column, select the

Daily maintenance

check box.

3. On the command menu, choose button.

1. Open the front cover and inspect all parts of the instrument deck and carriers.

o If the instrument deck is clean, choose the

OK

button. Continue with daily maintenance. o

If the instrument deck requires cleaning, choose the

Cancel

button and perform weekly maintenance.

1. Remove the support frame from the initialization/waste block.

2. Dispose of the solid waste bag in accordance with local regulations.

3. Replace the solid waste bag.

4. Remove and clean the tip eject plate with disinfectant solution. Put the clean tip eject plate back in place.

5. Choose the

OK

button.

Automatically performed by the instrument.




213

Weekly maintenance on the pooling instrument

Steps

1

Start weekly maintenance.

The weekly maintenance on the pooling instrument includes the following steps:

User action

1. In the

Maintenance

group box of the pooling instrument manager, choose the


button.

2. From the list of maintenance actions, in the

Execute

column, select the

Weekly maintenance

check box.

3. On the command menu, choose the button.

2

Remove and clean the carriers.

3

Check tightness of pipetting channels.

4

Verify proper function of liquid level detection

5

Clean the instrument deck.

1. Remove all carriers from the autoload tray.

2. Choose the

OK

button.

3. Clean the carriers.



1. Open the front cover.

2. Clean the instrument deck.

3. Choose the

OK

button.

6

Empty the tip waste.

7

Clean the tip eject plate, the laser scanner window, the covers, and the autoload protecting ribbon.

y

Quick reference: Weekly maintenance

1. Remove the support frame from the initialization/waste block.

2. Dispose of the solid waste bag in accordance with local regulations.

3. Replace the solid waste bag.

1. Remove and clean the tip eject plate with disinfectant solution. Put the clean tip eject plate back in place.

2. Choose the

OK

button.


214 Weekly maintenance on the pooling instrument


Troubleshooting

13 Troubleshooting ....................................................................................................217


Troubleshooting

Table of contents

217

13

In this chapter

13

Troubleshooting on the Microlab

®

STAR IVD. . . . . . . 219

Resolving hardware errors on the Microlab

®

STAR IVD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 219

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 219

Loading and unloading errors . . . . . . . . . . . . . . . . 220

Sample barcode reading error . . . . . . . . . . . . . 220

Carrier loading error. . . . . . . . . . . . . . . . . . . . . . 221

Carrier identification error . . . . . . . . . . . . . . . . . 221

Carrier unloading error . . . . . . . . . . . . . . . . . . . 223

Consumable identification error . . . . . . . . . . . . 224

Pipetting errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 226

Pipette tip pickup error . . . . . . . . . . . . . . . . . . . 226

Pipette tip eject error . . . . . . . . . . . . . . . . . . . . . 226

Pipetting error . . . . . . . . . . . . . . . . . . . . . . . . . . . 227

Control unit unresponsive . . . . . . . . . . . . . . . . . . . . 228

Moving the autoloader manually . . . . . . . . . . . . . . 229

Cleaning laser window of barcode reader on autoloader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 230

Placing carriers when a stop hook is broken . . . . 232

Troubleshooting on the data manager. . . . . . . . . . . . . 233

Resolving alarms in the data manager . . . . . . . . . 233

Reports for troubleshooting in the data manager 234

Creating a problem report in the data manager. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 234

About the alarm report in the data manager . 235

List of data manager messages . . . . . . . . . . . . . . . . . . 236


218

Table of contents


Troubleshooting

219

Troubleshooting on the Microlab

®

STAR

IVD

Follow the outlined instructions to resolve errors on the pooling instrument.

In this section

Resolving hardware errors on the Microlab

®

STAR

IVD (219)

Loading and unloading errors (220)

Pipetting errors (226)

Control unit unresponsive (228)

Moving the autoloader manually (229)

Cleaning laser window of barcode reader on autoloader (230)

Placing carriers when a stop hook is broken (232)

Resolving hardware errors on the Microlab

®

STAR IVD

Overview

A

When a problem occurs on the Microlab

®

STAR IVD, an error message is displayed describing the problem.

The error dialog box contains information describing the error and includes one or more buttons to allow the user to recover from the error situation.

The various types of hardware errors that may occur during operation of the pooling instrument are listed below.

• Loading and unloading carriers

• Barcode identification

• Picking up and ejecting pipette tips

• Aspiration and dispensing liquids

• Database

B

A

Error descriptions

B

Operation buttons


220 Troubleshooting on the Microlab

®

STAR IVD

NOTICE

Damage to the pooling instrument due to inappropriate error handling

The loading mechanism may be damaged or the run may be stopped, when using the wrong buttons in the error dialog box.

r Only use the operation buttons described in the User

Guide. Other operation buttons are reserved for customized error handling and may not have been assigned.

Loading and unloading errors

Sample barcode reading error

If an error occurs reading a sample barcode label, the run pauses and the

Load Carrier - Error

dialog box is displayed, indicating the erroneous sample.

1

r

To resolve a sample barcode reading error

1

Choose the

Unload Carrier

button.

f The sample carrier is unloaded.

2

Choose the

Barcode

button.

f The

Insert Barcode


3

3

Using the hand-held barcode reader, enter the barcode ID of the selected sample tube twice.

4

Choose the

OK

button.

5

Place the sample tube back on the sample carrier, slide the sample carrier slightly forward to the stop hooks, and choose the

Execute

button.

f

The sample carrier is re-loaded.


Troubleshooting

221

Carrier loading error

Carrier identification error

1

If an error occurs while loading a carrier, the run pauses and the

Load Carrier - Error


r

To resolve a carrier loading error

1

NOTICE Do not choose the

Unload Carrier

or

Cancel

buttons. Damage to the loading mechanism may result.

1 Choose the

Repeat

button.

f

The

Repeat the command

entry is displayed for each position in the

Assigned barcodes/recovery

field.

2

Choose the

Execute

button. f

A dialog box is displayed with instructions to pull the carrier back to the loading position.

3

Pull the carrier back to the loading position. Then slide the carrier forward slowly and carefully until it engages the stop hook at the end of the autoload tray.

4

Choose the

OK

button.

I

If the problem persists, call Roche Service.

If an error occurs reading a carrier barcode label, the run pauses, the carrier is returned to the autoload tray, and the

Identify - Error


An error description explains the reason for the error.

Possible causes include:

• An incorrect carrier was loaded.

• The carrier barcode label could not be read.



®

STAR IVD

2

r

To replace an incorrect carrier

1

When the carrier is returned to the autoload tray, remove the incorrect carrier from the autoload tray and replace it with the correct carrier.

2

In the

Identify - Error


Repeat

button.

3

Choose the

Execute

button.

f

The new carrier is loaded and the run continues.

r

To repeat reading the carrier barcode label

1

When the carrier is returned to the autoload tray, remove the carrier and check the integrity of the carrier barcode label.

2

If the barcode label is damaged or otherwise unreadable, either replace the carrier or enter the barcode ID manually.

3

Slide the carrier back into position on the autoload tray.

4

Choose the

Repeat

button and then the

Execute

button. The carrier is reloaded and the barcode label is read again.

5

If the attempt to read the barcode label is still unsuccessful, enter the barcode ID manually.


Carrier unloading error

Troubleshooting

223

If an error occurs while unloading a carrier, the

Unload

Carrier - Error


r

To resolve a carrier unloading error

1

NOTICE Do not choose the

Abort

or

Cancel

buttons.

Either command aborts the run.

1 Choose the

Repeat

button.

f

The

Repeat the command

entry is displayed in the

Assigned recovery

field.

2

Choose the

Execute

button.

f

A dialog box is displayed with instructions to unload the carrier manually.

3

Remove the carrier from the autoload tray.

4

Choose the

OK

button.

5

If the software freezes, the run must be aborted.

Restart the control unit.

u

Related topics

• Control unit unresponsive (228)



®

STAR IVD

Consumable identification error

If the barcode label of a carrier is read successfully but an error occurs during barcode reading of a tube or aliquot plate, the carrier is returned to the autoload tray and the

Manual ID entry


The dialog box describes the location of the item with the error.

Three recovery options are available:

Button

Back

Retry

OK

Recovery Option

Unload and reload the previous rack.

Repeat the barcode reading.

Manually enter the barcode ID using the hand-held barcode reader or the keyboard.

y

Recovery options

Always start by choosing the

Retry

button unless it is obvious that the pooling instrument cannot read the barcode label.

r

To repeat reading of a barcode label

1

Check the integrity and position of the barcode label.

Reorient the item if necessary.

I

If the barcode label is damaged or otherwise unreadable, enter the barcode ID manually.

2

Slide the carrier back into position on the autoload tray.

3

Choose the

Retry

button. The carrier containing the item with the barcode reading error is reloaded and the barcode label is read again.

4

If the pooling instrument again fails to read the barcode label, enter the barcode ID manually.


Troubleshooting

225

r

To enter a consumable barcode manually

1

Verify that the cursor is flashing in the top

Id

field.

2

Using the keyboard or hand-held barcode reader, enter the barcode ID of the selected sample tube, aliquot plate, or tip rack.

I

Ensure the barcode ID being entered is for the item indicated in the

Track

and

Position

fields.

Make sure that Caps Lock is turned off on the keyboard. If Caps Lock is turned on, the barcode label might be read incorrectly.

3

Using the keyboard or hand-held barcode reader, reenter the barcode ID in the bottom

Id

field.

I

Asterisks (*) replace the entry. If the first and second barcode ID entries match, the

OK

button is enabled.

4

Choose the

OK

button.

5

If a barcode reading error occurred for more than one barcode, another

Manual ID entry

dialog box is displayed listing the location of the next item. Repeat the procedure starting from step 1.

6

When all of the required barcode IDs have been entered, choose the

OK

button.

f

The carrier is reloaded and the run continues.



®

STAR IVD

Pipetting errors

Pipette tip pickup error

1

If an error occurs while picking up a pipette tip, a dialog box is displayed.

r

To resolve a pipette tip pickup error

1

When no pipette tips are available a dialog box is displayed.

• Choose

OK

to load new pipette tips.

• Choose

Cancel

to abort the run.

Pipette tip eject error

1

If an error occurs while ejecting a pipette tip, the

Tip

Eject - Error


r

To resolve a pipette tip eject error

1

The recovery procedure depends on whether the pipette tip was ejected or not.

• If the pipette tip is still present on the pipetting channel, choose the

Continue

button. The pipette tip is ejected and the run continues.

• If the pipette channel still cannot eject the pipette tip, choose the

Stop

button and the

Pooling

Wizard

aborts the run, unloading all the consumables. Follow the on-screen instructions to eject the pipette tips.

• If the pipette tip is not present on the pipetting channel, choose the

Continue

button to continue the run.

2

If the software freezes while aborting the run, restart the control unit. u

Related topics

• Control unit unresponsive (228)


Pipetting error

Troubleshooting

227

If a pipetting error occurs during pipetting of a sample or pool, the system performs recovery procedures.

If the sample is still not successfully pipetted, the sample tube must be included in another pooling run. The samples excluded from a run are listed in the

Pending pools

list on the data manager, along with the assigned pooling order.

The samples excluded from a run can be found as follows:

• In the

Pending pools

list on the data manager, along with the assigned pooling order

• In the Samples to reload report

The user is notified of the pipetting error by a message displayed in the message section of the data manager. u

Related topics

• Resolving alarms in the data manager (233)

• cobas Synergy reports (175)



®

STAR IVD

Control unit unresponsive

If a control unit is unresponsive, restart the control unit. q

Wait until a pooling run completes before restarting the control unit.

r

To restart an unresponsive control unit (preferred method)

1

Press the Windows key on the keyboard to display the

Windows

Start

menu.

2

In the

Turn off Computer

menu, choose the

Restart

command.

r

To power off an unresponsive control unit

1

If the computer is completely locked, press the power button and hold it down for 5-10 seconds until the control unit powers off.

2

Wait for about 10 seconds, then press the power button on the control unit again.


Troubleshooting

229

Moving the autoloader manually

To recover from an error, it might be necessary to move the autoloader manually to gain unrestricted access to the instrument deck.

j m

The pooling instrument is in an error situation.

r

To move the autoloader manually

1

Switch off the pooling instrument.

1

2

2

Open the front cover.

3

3

Touch the body plate of the autoloader and gently move the autoloader rightwards to its parking position.

I

Never touch the barcode reader on the autoloader.

This could change the alignment of the barcode reader, resulting in barcode reading errors.



®

STAR IVD

4

4

Close the front cover.

Cleaning laser window of barcode reader on autoloader

If there are barcode reading errors when loading carriers, the laser window of the barcode reader must be cleaned.

d m

Disposable lab gloves m Lab coat m

Eye protection m Lint-free cloth m

Ethanol (70%) j m Frequent barcode reading errors when loading carriers r

To clean the laser window of the barcode reader on the autoloader

1

Switch off the pooling instrument.

1

2

2

Open the front cover.


Troubleshooting

231

3

3

Touch the body plate of the autoloader and gently move the autoloader to a position for cleaning the window of the barcode reader.

I

Never touch the barcode reader on the autoloader.

This could change the alignment of the barcode reader, resulting in barcode reading errors.

4

4

Clean the laser window of the barcode reader with a lint-free cloth moistened with 70% ethanol.

I The laser windows of the barcode readers must be completely dry and free from dust and fibers before the pooling instrument can be reused.

5

5

Close the front cover.



®

STAR IVD

Placing carriers when a stop hook is broken

When placing carriers on the autoload tray, they are stopped by a hook to allow the autoloader to detect the carrier. On tracks with a broken stop hook, the carrier must be visually lined up to prevent a crash.

j m

Broken stop hook

2

r

To place carriers on the autoload tray when a stop hook is broken

1

If possible, do not use tracks with a broken stop hook.

2

If you cannot insert the carrier on another, undamaged track, insert the carrier on the autoload tray and visually line up the carrier to allow the autoloader to detect the carrier.

I

Do not insert the carrier beyond the broken stop hook to avoid the autoloader from crashing into the carrier. As a reference, you can use an unaffected track with a fully inserted carrier waiting for loading.

3

Call Roche Service to replace the broken stop hook.


Troubleshooting

233

Troubleshooting on the data manager

To resolve problems on the data manager you can create a problem report or an alarm report.

In this section

Resolving alarms in the data manager (233)

Reports for troubleshooting in the data manager (234)

Resolving alarms in the data manager

Alarm report

Messages from different sources are collected in the message section of the data manager.

The message section has the following functions:

• Indicating occurrence, severity, and number of messages

• Accessing the messages panel

The usage of the message section is described in detail in the overview of the

cobas Synergy

software.

u

Message section (79)

You can also create an alarm report with selected messages. u

About the alarm report in the data manager (235)

u


r

To resolve alarms in the data manager

1

In the global information area, choose the message section.

I

The first number in the tab headers indicate the number of unacknowledged messages.

2

Choose one of the message tabs and choose the messages that you want to acknowledge.

I

Unacknowledged messages are displayed in bold.


234 Troubleshooting on the data manager

3

3

Choose the

Acknowledge

button.

4

If required, take the necessary actions to resolve the problems that are indicated by the messages.

Reports for troubleshooting in the data manager

The data manager offers reporting functionalities for troubleshooting purposes.

u


In this section


About the alarm report in the data manager (235)

Creating a problem report in the data manager

If there are problems on the data manager, you can create a problem report to assist Roche Service in resolving the issue.

A problem report includes information about the following items:

• Error log files

• Configuration files

• Database configuration content

• Any screenshots in the problem report location j m

A problem occurred that needs support from Roche

Service.


Troubleshooting

235

1

r

To create a problem report

1

In the global information area of the data manager, choose

System > Problem reporter

.

f

The

Backup database and configuration


2

2

Choose the button and select a location for the problem report.

3

To create a compressed zip file of the problem report, choose the

Compress backup to .zip file

option.

• Optionally, choose the

Remove files after compression

option.

About the alarm report in the data manager

Other reports for troubleshooting

An alarm report is a

cobas Synergy

report for troubleshooting purposes.

The alarm report collects messages from components and functions of the

cobas Synergy

solution.

An alarm report is created in the same way as other

cobas Synergy

reports.

The data manager includes further

cobas Synergy

reports that can be used for troubleshooting purposes:

• Initial reactive pools report

• Sample audit report u


u

Related topics

• Creating a cobas Synergy report (178)


236 List of data manager messages

List of data manager messages

Messages on the data manager are displayed in one of these places:

• Message section

• Dialog boxes

• Additional sample information (

Routine > Sample history

)

ID

AM00001

AM00002

AM00003

AM00005

AM00008

Message text

[AM00001] Test orders for sample/pool {ID} were rejected by the instrument.

[AM00002] Result for sample {ID} is invalid.

[AM00003] Result for pool {ID} is invalid.

[AM00005] Pool {PoolId} is invalid and will be ignored.

[AM00008] Result for tube ID % has been ignored. It contains negative or positive results.

AM00009 [AM00009] Test code, sample type - HL7 code and pipetting volume of the result do not match any configured test.

y List of data manager messages

Description

Possible causes: o

Malformed message

Recommended actions: o

Contact your Roche Service representative.

No action required.

u


No action required.

u


Possible causes: o

You have rejected the loaded pool.

o

The loaded pool has not enough transferred samples.

o

Mixing failed for the loaded pool.

No action required.

u

Handling invalid pools (165)

Possible causes: o

The result message from the analyzer contains a NEG or

POS result instead of an NR or RR result.






Troubleshooting

237

ID

ARC0001

BAC0001

BAC0003

BAC0006

Message text

[ARC0001] Selected archive location is not accessible.

[BAC0001] Backup file % could not be deleted from folder %. Delete this file manually.

[BAC0003] Selected backup folder could not be accessed. It has been saved locally in folder: %

[BAC0006] Temporary backup location ’%’ is not available. Backup task of database ’%’ cannot continue.

Description

Which actions are available is different for each laboratory. It depends on access rights and configuration.


Check the configuration.

o

Check if the location is accessible.

o

If you cannot solve the problem, contact your Roche


u





o

Check if the configured backup folder is accessible.

o



u





o

Check if the configured backup folder is accessible.

o

Copy the backup files to the backup folder.

o

If the problem occurs repeatedly, contact your Roche


u



Possible causes: o

The configured folder was accidentally deleted.

Recommended actions:

1. Check if the folder that is defined in the configuration actually exists.

2. Check if the configured folder is accessible.

3. When you have solved the problem, perform a manual backup.

4. If the same problem occurs during manual backup, contact your Roche Service representative.

u





ID

BAC0007

BAC0008

CON0013

CON0016

CON0023

CON0027

CON0028

Message text

[BAC0007] Insufficient storage space to save the database files (*.mdf and *.ldf) in the temporary backup location.

[BAC0008] Selected backup location is not accessible.

[CON0013] Test cannot be edited at this time because it has been assigned to samples on the worklist.

[CON0016] Target cannot be edited at this time because it has been assigned to samples on the worklist.

[CON0023] Connection details could not be verified. Do you want to save?

[CON0027] An error has occurred while saving the settings in the database.

[CON0028] An error has occurred while saving the item to the database.

Description



Make sure that there is sufficient space on the hard disk.

o


u





o

Check if the backup location is accessible.

o


u



Wait until the worklist for this test is complete, then try again.

o

If the pooling runs are still in

Pending

status in the

Pending pools

panel, reject the pooling runs. Then try again.

u



Wait until the worklist for this target is complete, then try again.

o

If the pooling runs are still in

Pending

status in the

Pending pools

panel, reject the pooling runs. Then try again.

u





u



If you cannot solve the problem, create a problem report and send it to your Roche Service representative.

u


u




u


u




Troubleshooting

239

ID

CON0029

CON0036

CON0038

CON0039

CON0040

EB0001

EB0002

EB0003

EB0004

Message text

[CON0029] An error has occurred while deleting the item from the database. Item could not be deleted. Check log file for details.

[CON0036] Network folders could not be found. Check the connection settings.

[CON0038] An error has occurred while configuring the database backup schedule.

SSIS job "XTPoolingBackup" might not exist or is inaccessible.

[CON0039] An error occurred while starting the backup task.

[CON0040] An error occurred while starting the archive task.

[EB0001] Server dongle record could not be updated. File could not be found at path: %

[EB0002] Server dongle record could not be updated. Access was denied.

[EB0003] Server dongle record could not be updated. File could not be found.

[EB0004] Server dongle record could not be updated. y List of data manager messages

Description



u


u





u


Possible causes: o

There is a problem with the connection to the SQL Server

Agent Service.



u


u





u





u












ID

EB0005

EB0006

EB0008

EB0009

EB0010

EB0011

EB0012

EB0013

EB0014

EB0015

EB0016

PM0001

Message text

[EB0005] Following detected file could not be accessed: %

[EB0006] The server dongle has been removed from the main terminal. No sample processing is performed until the dongle is reconnected and the software restarted.

[EB0008] Connection to IG server {IG_IP} was interrupted.

Description

Possible causes: o

An exclusion list or PVT import file is not accessible.


Make sure that the file is not open in another application.

o

Make sure that the file is accessible.

For the location of the file, choose

Administration

> General settings > Global settings

.

o



u

Additional general settings (273)

Possible causes: o

The master dongle (USB flash drive) was pulled out or is not correctly inserted.


Make sure the master dongle (USB flash drive) is correctly inserted.

o




1. Restart the system.

2. If you cannot solve the problem, contact your Roche


[EB0009] Incoming connection from IG server

{IG_IP} is not allowed. IG server is not configured.



u

Connecting instruments (270)

[EB0010] The following ASTM file is invalid: % Recommended actions: o


No action required.

[EB0011] CSV file % has already been imported previously and will not be imported again.

[EB0012] File name pattern of the CSV file % is invalid.

[EB0013] Folder for import data % could not be found. A new folder will be created.

[EB0014] Folder containing list of seropositive samples could not be found. The same folder will be used as for WNV individual donor testing.

[EB0015] Following detected ASTM file was ignored because it was previously imported: %

[EB0016] Following detected ASTM file was ignored because it does not match the filename pattern: %

No action required.

No action required.

No action required.

No action required.

No action required.

[PM0001] No connection could be made to pooling instrument {PoolerID}.



y



Troubleshooting

241

ID

PM0003

PM0004

PM0005

PM0007

Message text

[PM0003] No pooling runs can be found on pooling instrument: {PoolerID}

[PM0004] Pooling run has been canceled due to invalid run settings: %. Pooling instrument:

{PoolerID}. Run settings could not be found.

[PM0005] Pooling run has been canceled due to invalid run settings: %. Pooling instrument:

{PoolerID}. No tests were configured.

[PM0007] Pooling run has been canceled due to insufficient No. of samples. Pooling instrument: {PoolerID}

[PM0008] Pool {PoolID} is invalid.

o

Description







No action required.

PM0008

PM0011

PM0012

PM0013

PM0014

PM0015

PM0016

PM0018

PM0019

[PM0011] No tip rack found for pooling instrument {PoolerID}.

[PM0012] No data found for pooling instrument {PoolerID}.

[PM0013] Pooling run was canceled by the pooling instrument {PoolerID}.

[PM0014] Sample was rejected because of an aspiration error on instrument {PoolerID}.

[PM0015] Pooling run % on pooling instrument {PoolerID} is invalid.

[PM0016] Pooling runs with status other than

'Processing' will not be imported. (Pooling run status: %, Pooling run: %).

[PM0018] Sample rejected due to dispensing error: Pool %, Instrument {PoolerID}

[PM0019] Sample rejected due to mixing error:

Pool %, Instrument {PoolerID} y


Possible causes: o

You have aborted a pool run.

o

You have reused a pool tube.

o

An error during pipetting or mixing has occurred.

o

There are not enough samples.


1. Make sure you do not reuse pool tubes.

2. Check the minimum pool size.

3. Reload the samples and start a new pooling run.





No action required.

No action required.





No action required.

No action required.



ID

PM0022

PM0023

REP00001

REP00002

TM00001

TM00008

TM00009

TM00010

TM00014

TM00016

TM00030

Message text

[PM0022] Repeat loading action was performed on pooling instrument: {PoolerID}

[PM0023] Sample was rejected because mixing was ignored due to a dispensing error:

Pool %, Instrument {PoolerID}

[REP00001] An error has occurred while loading the reports from the server. (URL: "%")

Description

No action required.

No action required.

[REP00002] An error has occurred while loading the report from the report server.

[TM00001] Change request could not be completed.

[TM00008] An error has occurred while trying to reject pools. Check log file for details.

[TM00009] An error has occurred when trying to force unresolved results. See the log file for details.

[TM00010] An error has occurred while trying to mask tests. Check log file for details.


1. Create a problem report.

2. Send the problem report to your Roche Service representative.

u





u







u





u





u


If you choose the

Yes

button, only a subset of test orders is masked.

[TM00014] The following test orders do not have masking according to the run settings: %.

Do you really want to mask these test orders?

[TM00016] An error has occurred while recovering test orders. Check log file for details.

[TM00030] Data could not be exported.




u






Troubleshooting

243

ID

TM00031

TM00032

TM00033

TM00034

TM00035

TM00037

TM00040

TM00041

TM00042

Message text Description

[TM00031] Pooling run could not be rejected.

Details: %

[TM00032] Pool could not be rejected.

[TM00033] Force unresolved could not be completed.

[TM00034] Mask could not be completed.









[TM00035] Test order could not be recovered. Recommended actions: o


[TM00037] Results were not validated.



[TM00040] Data could not be sent.

[TM00041] Results were not rejected.





[TM00042] Comment could not be added.



y List of data manager messages u

Related topics

• Message section (79)

• Evaluating sample history (160)




Configuration

14 Configuration of pooling instrument manager..........................................247

15 Basic configuration of data manager............................................................255

16 The Configuration environment ......................................................................283

17 The Manager environment ...............................................................................299


Table of contents

247

Configuration of pooling instrument manager

14

In this chapter

14

Managing users on the pooling instrument manager 249

Administration tab . . . . . . . . . . . . . . . . . . . . . . . . . . 249

About user groups . . . . . . . . . . . . . . . . . . . . . . . . . . 251

Creating a user . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 252

Deleting a user . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 253

Changing a user’s password . . . . . . . . . . . . . . . . . . 254


248

Table of contents



249

Managing users on the pooling instrument manager

In this chapter, you find how to manage users on the

Administration

tab of the pooling instrument manager.

q

You must have Laboratory manager access rights to access the

Administration

tab.

In this section

Administration tab (249)

About user groups (251)

Creating a user (252)

Deleting a user (253)

Changing a user’s password (254)

Administration tab

On the

Administration

tab, choose the

User management

task button to display the

User management

panel.


250 Managing users on the pooling instrument manager

w

User management panel

On the

User management

panel, you can do the following:

• Create a user.

• Delete a user.

• Change a user’s password.


About user groups


251

User groups determine access rights. Each user must be assigned to a user group. You cannot create user groups.

The following user groups are available:

User group

User

Laboratory manager

Service

Access rights

Operation and maintenance actions on the

Routine

panel o

Operation and maintenance actions on the

Routine

panel o

User management on the

Administration

panel

For Roche Service only y User groups and associated access rights



Creating a user

You can create users and assign them to a user group

(Laboratory manager or User).

q

You cannot assign a user to the Service user group.

User name and password of each user must be unique.

j m

You must have Laboratory manager access rights.

2

r

To create a user

1

Choose

Administration > User management

.

2

On the

User management

panel, choose the

Add

button.

3

Enter the required information:

•

User:

Enter a name for the new user.

User names must be unique.

•

User group:

Choose a user group for the new user.

•

Password:

Enter a password for the new user.

Passwords must be unique.

•

Confirm password:

Enter the same password again for confirmation.

•

Description:

(optional)

Optionally, enter a description or comment for the new user.

4

Choose the

Save

button.



253

Deleting a user

You can delete a user.

j m


2

r

To delete a user

1

Choose


.

2

On the

User management

panel, choose a user from the table and choose the

Delete

button.

3

To confirm, choose the

OK

button.



Changing a user’s password

You can change a user’s password.

q

All users can change their own passwords in the

Logon

dialog box.

j m


2

r

To change a user’s password

1

Choose


.

2

On the

User management

panel, choose a user from the table.

3

Enter the new password in the

Password:

field and the

Confirm password:

field.

4

Choose the

Save

button.


Basic configuration of data manager

Table of contents

255

15

In this chapter

15

About basic configuration . . . . . . . . . . . . . . . . . . . . . . . 257

Administration tab . . . . . . . . . . . . . . . . . . . . . . . . . . 258

Basic configuration order . . . . . . . . . . . . . . . . . . . . 259

Configuring targets . . . . . . . . . . . . . . . . . . . . . . . . . . . . 260

Configuring tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 263

Configuring primary runs . . . . . . . . . . . . . . . . . . . . . . . 266

Assigning tests to IDT runs . . . . . . . . . . . . . . . . . . . . . . 268

Connecting instruments . . . . . . . . . . . . . . . . . . . . . . . . 270

Additional general settings . . . . . . . . . . . . . . . . . . . . . . 273

Processing results automatically . . . . . . . . . . . . . . . . . 275

Backing up databases . . . . . . . . . . . . . . . . . . . . . . . . . . 276

Archiving databases. . . . . . . . . . . . . . . . . . . . . . . . . . . . 279


256

Table of contents



257

About basic configuration

In this chapter, you find how to do basic configuration of the data manager on the

Administration

tab of the main work area.

u

About the data manager (77)

!

CAUTION

Incorrect results

Missing or incorrect basic configuration of the data manager may lead to incorrect results.

r Make sure to complete and to test basic configurations before using the data manager.

NOTICE

Basic configuration order

Performing the basic configuration tasks in the wrong order may lead to failed or inappropriate basic configurations.

r

Make sure to follow the basic configuration order described below.

u

Basic configuration order (259)

In this section

Administration tab (258)

Basic configuration order (259)

u

Related topics




258 About basic configuration

Administration tab

w Administration tab

On the

Administration

tab, there are the following task buttons:

•

Primary run settings

•

IDT run settings

•

Test

•

Target

•

Instrument

•


•

Result

•

Backup

•

Archive

Choose a task button to display the corresponding panel, where you can do the configuration.



259

Basic configuration order

Basic configuration must be done in the following order

(regardless of the order of the task buttons on the

Administration

tab):

1. Targets:

Define the individual targets you are looking for in the samples.

2. Tests:

Define tests consisting of one or several targets.

3. Primary runs:

Define primary runs consisting of a pool size, and one or several tests. q

An IDT run is a primary run without using a pool, i.e., tests are performed directly on individual samples.


260 Configuring targets

Configuring targets

On the

Administration

tab, choose the

Target


Target

panel.

q

You cannot edit targets which are assigned to samples on the worklist.

w

Target panel

New target panel

The

Target

panel lists all configured targets. In the panel, you can do the following:

• To create a target, choose the

Add

button.

• To change the configuration of a target, choose the target from the table and choose the

Edit

button.

On the

Target

panel, choose the

Add

button to display the

New target

panel.



261

w

New target panel

In the

Target

group box and the

Result representation

group box, enter the required information.

Target group box

Element

Name

field

LIS code

field

HL7 code

field

Quantitative

check box y

Elements of the Target group box

Description

Enter a name for the target.

Enter the LIS code of the target.

Enter the HL7 code of the target.

Select if the result of a test for this target is quantitative.

Result representation group box

In the

Result representation

group box, determine how the result values received from the analytic system are displayed in the data manager.

q

The screenshot shows an example only.


262 Configuring targets

Element

Value

column

Description

column

Description

Result value received from the analytic system.

Result representation in the data manager.

y

Elements of the Result representation group box

To add a row in the table, choose the

Add

button. To delete a row in the table, choose the row and choose the

Delete

button.



263

Configuring tests

On the

Administration

tab, choose the

Test


Test

panel.

q

You cannot edit tests which are assigned to samples in the worklist.

w

Test panel

Add test panel

The

Test

panel lists all configured tests. In the panel, you can do the following:

• To create a test, choose the

Add

button.

• To change the configuration of a test, choose the test from the table and choose the

Edit

button.

On the

Test

panel, choose the

Add


Add test

panel.


264 Configuring tests

w

Add test panel

In the

Test:

group box, the

Overall result representation

group box, and the

Targets


Test: group box

Element

Name

field

Sample type

field

Sample volume [ μ L]

field

LIS code

field

HL7 code

field y

Elements of the Test: group box

Description

Enter a name for the test.

Enter the sample type for the test.

Enter the sample volume in μ L for the test.

Enter the LIS code of the test.

Enter the HL7 code of the test.



265

Overall result representation group box

In the

Overall result representation

group box, determine how the result values received from the analytic system are displayed in the data manager.

q

The screenshot shows an example only.

Element

Value

column

Description

column

Description

Result value received from the analytic system.

Result representation in the data manager.

y

Elements of the Overall result representation group box

To add a row in the table, choose the

Add

button. To delete a row in the table, choose the row and choose the

Delete

button.

Targets group box

In the

Targets

group box, choose the button and the button to assign targets to the test:

Element

Available targets

table

Selected targets

table y

Elements of the Targets group box

Description

Lists all configured targets.

Lists all targets assigned to the test.


266 Configuring primary runs

Configuring primary runs

On the

Administration

tab, choose the




panel.

w Primary run settings panel

Create run settings panel

The


panel lists all configured primary run settings. In the panel, you can do the following:

• To create a primary run setting, choose the

Add

button.

• To change the configuration of a primary run setting, choose the setting from the table and choose the

Edit

button.

On the


panel, choose the

Add


Create run settings

panel.



267

w

Create run settings panel

In the

Run settings:

group box and

Tests:


Run settings: group box

Element

Pool size

drop-down list

Description

Choose the pool size (6, 24, or 96).

y

Elements of the Run settings: group box

Tests: group box

In the

Tests:

group box, choose the button and the button to assign tests to the primary run.

Element

Available tests

table

Selected tests

table y

Elements of the Tests: group box

Description

Lists all configured tests.

Lists all tests assigned to the primary run.


268 Assigning tests to IDT runs

Assigning tests to IDT runs

On the

Administration

tab, choose the




panel.

w

IDT run settings panel

IDT panel

You can define the tests for three IDT run settings. No pools are created in an IDT run. The samples are tested directly on the analytic system.

•

IDT SeroPos

for seropositive samples. Seropositive samples are managed in an exclusion list.

•

IDT WNV

for samples that need to be tested for West

Nile virus. They are managed in a separate exclusion list.

•

IDT Default

for tests that need no pooling but are always tested directly on the analytic system.

On the


panel, choose an IDT setting from the table and choose the

Edit

button to display the panel for the selected IDT run setting.



269

w

IDT panel

Tests: group box

In the

Tests:

group box, choose the button and the button to assign tests to the IDT run setting:

Element

Available tests

table

Selected tests

table y

Elements of the Tests: group box

Description

Lists all configured tests.

Lists all tests assigned to the IDT run.


270 Connecting instruments

Connecting instruments

On the

Administration

tab, choose the

Instrument


Instrument

panel.

w

Instrument panel

Add instrument panel

The

Instrument

panel lists all connected instruments. In the panel, you can do the following:

• To create an instrument, choose the

Add

button.

• To change the configuration of an instrument, choose the instrument from the table and choose the

Edit

button.

On the

Instrument

panel, choose the

Add


Add instrument

panel.



271

w

Add instrument panel

To connect a new instrument, do the following:

1. In the

Instrument

group box and the

Connection details


2. Choose the

Test Connection

button:

- If connection fails, the data manager displays

“[CON0022] Test connection failed”.

Correct the server and/or database details (for pooling instruments) or the IP address (for analytic systems) and try again.

- If connection succeeds, the data manager displays

“[CON0021] Test connection successful”.

3. Choose the

Save

button.

Instrument group box

Element

ID

field

Type

drop-down list

Description

Enter a numeric ID for the instrument.

Choose the instrument type: o


o

Analyzer

Depending on the chosen instrument type, different fields are enabled in the


group box.

y

Elements of the Instrument group box


272 Connecting instruments

Connection details group box

In the


group box, enter the communication way between data manager and instrument.

The available fields depend on the instrument type.

Element

Server

field (for pooling instruments only)

Database

field (for pooling instruments only)

IP address

field (for analytic systems only)

Description

Enter the server the pooling instrument is connected to.

Enter the database for the pooling instrument to write to.

Enter the IP address of the analytic system.

y

Elements of the Connection details group box



273

Additional general settings

On the

Administration

tab, choose the




panel.

The general settings can only be accessed from the data manager server. It is not possible to access the general settings from the client.

w General settings panel

In the

Global settings

group box and the

Instrument titer cutoff (IU/mL)


Global settings group box

Element

Sample ID retention period (0 -

365 days)

field

Description

Enter the number of days to keep sample IDs (default value: 365). After this time period, the sample ID can be reused.

Enter “0” to disable sample ID retention.

y Elements of the Global settings group box


274 Additional general settings

Element

List of samples excluded from pooling for WNV testing

field

List of excluded seropositive samples

field

Path for pre-analytic system settings

field

Description

Enter the file path to the exclusion list for samples that have to be tested for WNV.

Samples in this list are excluded from pooling for WNV testing.

Choose the

Browse

button to choose the folder from the folder tree.

Default location is

C:\WNV

.

Enter the file path to the exclusion list for samples that were already tested seropositive for a test. Samples in this list are excluded from pooling for all tests configured as IDT seropositive.

Choose the

Browse


Default location is

C:\SeroPos

.

Laboratories using a pre-analytical system for sorting sample tubes can upload the sorting files to the data manager. The sorting files contain tube IDs, tube positions, and rack IDs. When loading the sorted racks onto the pooling instrument, the position and rack ID are then shown in the data manager after tube identification.

Enter the file path to the folder where the pre-analytical system stores the sorting files:

Choose the

Browse


Default location is

C:\PVT

.

y Elements of the Global settings group box

Instrument titer cutoff (IU/mL) group box

In the


group box, enter values for the titer cutoff and the minimum pool size for each pool size.

Element


field


field

Description

Enter the value (in IU/mL) to change the titer cutoff value for the active pool size.

Click the arrows to choose the minimal number of samples for the active pool size

(except 1).

After a pooling run, pools with less samples are displayed in bold on the

Pending tests

panel of the

Routine

tab. This indicates that the intended number of tests may not be possible.

Therefore, if more than one test is configured, masking of tests may be necessary.

y

Instrument titer cutoff (IU/mL) and Minimum pool size

Use the following table to set the minimum pool size and to calculate any residual pooling volume that can be used for re-testing.

Number of tests One test Two tests Three tests Four tests Pipetting volume per sample [ μ L]

Minimum required volume for testing [ μ L]

3610

PP96

PP24

PP6*

1000 1870 2740


27 50 73

11

5

20

5 n/a n/a

*For PP6, a minimum number of 5 aliquots is required.

95 n/a n/a

38

94

374 y Minimum pool size



275

Processing results automatically

On the

Administration

tab, choose the

Result


Result

panel.

w

Result panel

Settings on the

Result

panel determine what happens to pools that are processed and completed.

Results settings group box

Element

Validate results automatically

check box

Release results automatically

check box

Description

Select for automatic validation of processed and completed results.

Clear for manual validation of processed and completed results.

Select for automatic release of validated results to LIS.

Clear for manual release of validated results to LIS.

y

Elements of the Results settings group box


276 Backing up databases

Backing up databases

NOTICE

Sensitive information

Backup files contain information related to test results.

r

Make sure to store backup files according to applicable security procedures.

On the

Administration

tab, choose the

Backup


Backup

panel.

w Backup panel

To perform a full backup of the active database, enter the required information and choose the

Backup

button.

q

Backup generation is an online process. You do not have to stop sample processing in

cobas Synergy

solution.



277

During the backup process two databases (XT_Pooling and DSN_List) are backed up in a backup file. The data manager names the backup files

<db_name>_<DDMMYYYYhhmm>.bak

:

•

<db_name>

is the name of the current database.

•

<DDMMYYYYhhmm>

is the date and time when the backup process has taken place.

The backup settings can only be accessed from the data manager server. It is not possible to set up or create a backup from the client.

Backup settings group box

Element

Automatic backup

check box

Backup start time

field

Keep all backups

check box

Retained backups

field

Description

Select to schedule a daily automatic backup.

Enter the start time for the automatic backup (24-hour format hh:mm).

Select to keep all generated backup files.

If the

Keep all backups

check box is cleared, enter the number of backup files that are kept.

When the maximal number of backup files is reached, the data manager removes backup files starting with the oldest file.

y Elements of the Backup settings group box

Backup location group box

In the

Backup location

group box, determine where to store backup files.

q

Make sure that there is enough disc space available in the backup file location.

You get a warning message if more than 95% of the disc space in the backup file location is used.


278 Backing up databases

Element

Network/Local

option

SFTP location

option

Description

Select to store the backup file in the default location

D:\AURORA_Backup

locally on the computer you are working on. Do not change the default backup location.

The local backup folder is created upon software installation and cannot be changed.

Select to store the backup file remotely in a network folder.

Enter the required fields: o

Host name

field:

Host name of the server o

Host key

field:

Used to verify the server’s identity (if applicable) o

Port

field:

Connection port number (22 by default) o

User name

field:

Account user name o

Password

field:

Account password o

Private key file

field:

Specify if using public/private key authentication o

Remote folder

field:

Backup folder location

If the remote folder is not accessible or has not enough disc space, the backup file cannot be created.

y

Elements of the Backup location group box



279

Archiving databases

NOTICE

Sensitive information

Archive files contain information related to test results.

r

Make sure to store archive files according to applicable security procedures.

NOTICE

System performance

Data overload can influence system performance.

r

Perform database archiving regularly.

On the

Administration

tab, choose the

Archive


Archive

panel.

q

Archiving is an online process. You do not have to stop sample processing in

cobas Synergy

solution.

w

Archive panel

To create an archive of the active database, enter the required information and choose the

Archive

button.


280 Archiving databases

During archiving, the data is transferred to a separate archive database called

<db_name>_Archive

, where

<db_name>

is the name of the currently active database.

The archive settings can only be accessed from the data manager server. It is not possible to set up or create an archive from the client.

Archive settings group box

In the

Archive settings

group box, determine where to store archives.

q

Make sure that there is enough disc space available in the archive file location.

You get a warning message if more than 95% of the disc space of the archive file location is used.

Element

Network/Local

option

SFTP location

option

Description

Select to store the archive in the default location

D:\AURORA_Archive

locally on the computer you are working on. Do not change the default archive location.

The local archive folder is created upon software installation and cannot be changed.

Select to store the archive file remotely in a network folder.

Enter the required fields: o

Host name

field:

Host name of the server o

Host key

field:

Used to verify the server’s identity (if applicable) o

Port

field:

Connection port number (22 by default) o

User name

field:

Account user name o

Password

field:

Account password o

Private key file

field:

Specify if using public/private key authentication o

Remote folder

field:

Backup folder location

If the remote folder is not accessible or has not enough disc space, the archive file is retained.

y

Elements of the Archive settings group box

Accessing an archive database

To access the last stored local archive database, choose the

Change database

command in the database section of the data manager. Confirm that you want to change the database.



281

w

Select database dialog box

In the

Select database

dialog box, choose the archive database, and choose the

OK

button.

q

To access an archive that is stored on a remote location, the archive must first be copied to the local server and be restored before it can be accessed.


282 Archiving databases


Table of contents

283

The Configuration environment

16

Advanced configuration of data manager

In this chapter

16

The Configuration environment of the data manager 285

Accessing the Configuration environment . . . . . . 285

About the Configuration environment . . . . . . . . . . 286

Menu overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 287

Configuring LIS export. . . . . . . . . . . . . . . . . . . . . . . . . . 288

LIMS export configuration dialog box . . . . . . . . . . 289

Map-file editor dialog box. . . . . . . . . . . . . . . . . . . . 291

Creating messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 294

Annunciator configuration window . . . . . . . . . . . . 294

Categories tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 295

Message levels tab . . . . . . . . . . . . . . . . . . . . . . . . . . 296

Message configuration tab . . . . . . . . . . . . . . . . . . . 298


284

Table of contents



285

The Configuration environment of the data manager

Access the Configuration environment and the Manager environment, respectively, for advanced configuration of the data manager.

In this chapter, you find how to use the Configuration environment.

q

The menu paths given below at the beginning of each section are the absolute paths starting from the data manager.

In this section

Accessing the Configuration environment (285)

About the Configuration environment (286)

Menu overview (287)

u

Related topics


Accessing the Configuration environment

1

r

To access the Configuration environment

1


System > Configuration

.

f

The Configuration environment is displayed.


286 The Configuration environment of the data manager

About the Configuration environment

f

System > Configuration

A

C

B

A

Menu

B

Logged in user w

Configuration environment

Navigation buttons

C

Navigation buttons

D

Active database

Displays the Manager environment u

About the Manager environment (302)

Returns to the data manager

Displays the User Assistance

D



287

Menu overview

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LIMS settings

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Overview of the Configuration environment menu structure q

Access to commands depends on user rights.

The commands from the

Report

menu apply to Aurora reports. The Aurora report runner is a legacy functionality to create reports. This report runner cannot include parts of the information available in the database, and required for reports in

cobas Synergy

solution. It will only be available in the first version of

cobas Synergy

solution and removed in later versions. It is recommended not to use the Aurora report runner.


288 Configuring LIS export

Configuring LIS export

Automatic data upload from the data manager to the laboratory information system (LIS) is done via export files. Choose the

Configure export

command to configure the following:

• Which data the data manager includes in export files.

• How the data manager formats export files.

• The location where the data manager stores export files.

!

CAUTION

Incorrect data upload to LIS

Incorrect configuration of LIS export may result in incorrect data in the LIS.

r Make sure to configure LIS export correctly to deliver correct data from the data manager to the LIS.

You can implement several LIS export configurations and switch between these configurations.

In this section

LIMS export configuration dialog box (289)

Map-file editor dialog box (291)



289

LIMS export configuration dialog box

f

System > Configuration > Instruments > LIMS settings > Configure export

Choose the

Configure export

command. The

LIMS export configuration

dialog box is displayed, where you can do the following:

• Create a LIS export configuration

• Change a LIS export configuration

• Delete a LIS export configuration

You cannot delete the default export configuration.

Configuration group box

Use the following options in the

Configuration

group box to create or change an LIS export configuration:

Element

Format name

field

Map file

field

Target folder

field

Target filename

drop-down list

All tests were successfully validated

boxes

and

Single test

check

Description

Enter the name of the export configuration.

The map file determines how the data manager formats export files and which data is included in export files.

Choose the button to display the

Map-file editor

dialog box to either choose a map file or to create a map file. u

Map-file editor dialog box (291)

Choose the button to browse for the folder to store export files.

Choose the file name of the export file from the list or enter a new name. Make sure to choose a file ending corresponding to the export file format set in the

Map-file editor

dialog box.

Choosing a file name without time stamp overwrites the export file in the target folder.

Use these check boxes to determine the test validation status necessary for samples before export: o

Both check boxes cleared:

Samples are not required to have a completed validation status for any associated tests before export.

o

All tests were successfully validated

check box selected:

Samples must have a completed validation status for all associated tests before export.

o

Single test

check box selected:

Samples with a completed validation status for a test are exported for that test.

It is not possible to select both check boxes at the same time.

y

Elements of the Configuration group box



Element

Worklist complete all tests

and

Single test

check boxes

Approved only

No Errors

check box

check box

Use LIS test name

check box

Description

Determine the worklist status necessary for samples before export: o

Both check boxes cleared:

Samples are exported for a test even if they remain on the worklist for that specific test.

o

Worklist complete all tests

check box selected:

Samples that remain on the worklist for any test are not exported.

o

Single test

check box selected:

Samples that have no worklist entries for a specific test are exported for that test.

It is not possible to select both check boxes at the same time.

Select this check box to export approved samples only.

Select this check box to export samples without associated errors only.

Select this check box to use the LIS test name (if defined) instead of the test name in the export file.

y

Elements of the Configuration group box



291

Map-file editor dialog box

The map file determines which data is included in export files and how the data manager formats export files.

In the

Map-file editor

dialog box, you can do the following:

• To create a map file, choose

File > New Export

Format

.

Choose between the

ASTM E-1394

command, the

Character separated Values (CSV)

command, and the

XML

command.

The

Map-file editor

dialog box with the corresponding export configuration panel is displayed.

• To open a map file, choose

File > Open Map File

.

• To save a map file, choose

File > Save Map File

or

File > Save Map File As

.

ASTM export configuration panel

ASTM E-1394 is a standard for communication between clinical instruments and computer systems.

A

A

Definition row w

ASTM export configuration panel

In the

ASTM export configuration

panel, enter the required information:

Element

Description

field

Add definition

link

Data

drop-down list

Description

Enter a description of the map file.

Add a new definition row.

Choose the data fields that you require within your map file from a pre-defined list.

y

Elements of the ASTM export configuration panel



Element

Default data

field

Rec Type

ASTM Field

Comp

drop-down list

field

drop-down list

Description

Enter a default data value to stop the file from being blank within the export file if no value is returned from the database.

Choose the type of record for the selected data field from a pre-defined list (

H

,

P

,

O

,

R

,

Q

, or

C

).

Choose the ASTM field from a pre-defined list, which depends upon the data field and record type selected.

Choose the component number for the selected data. The available values depend upon the selected data and those values allowed within the ASTM1394 specification for that data.

y

Elements of the ASTM export configuration panel

CSV export configuration panel

A

A

Definition row w

CSV export configuration panel

In the

CSV export configuration

panel, enter the required information:

Element

Description

field

Use Quoted fields

check box

Delimiter

field

Add definition

Data

Default data

Field

field

link

drop-down list

field

Description


Determine if fields within quotes are allowed within the export file: o

When the check box is selected, quotes can enclose fields within the CSV file.

o

When the check box is cleared, quotes cannot enclose fields within the CSV file.

Enter the character to be used to delimit data fields within the CSV export file. The default character is “,”.

Add a new definition row.



Choose the field number for the selected data.

y

Elements of the CSV configuration panel



293

XML export configuration panel

C

D

A

B

E

A

Root node

B

Element (“Child2” is the child of “Root” and the sibling of

“Child1”, “Child3”, and “Child4”)

C

Text element

D

Attribute

E

XML structure area w

XML export configuration panel

In the

XML export configuration

panel, add the required elements:

Element

Description

field

Node/attribute name

field

Data

drop-down list

Default data

field

Add Root node

Update

Delete

button

button

button

Add Sibling element

Add Child element

Add Text node

Add Attribute

button

button

button

button

Description


Enter the name for the XML element or attribute.



Set the root node to be added to the XML structure area. Only one root node is allowed in an XML structure.

Add extra levels to the selected element at the same hierarchical level as the “child” level.

A sibling level is a hierarchical level at the same level as the selected element.

Add a child level to the selected element. A child level is a hierarchical level lower than the selected element. The child element is added to the XML structure area below the selected element.

Add a text level to the structure. The text element is an element that contains a data value. Choose a data value from the

Data

drop-down list before choosing the

Add Text node

button.

Add an attribute level to the structure. An attribute is a property of an element and must have a name and data value.

Update an element or attribute after changing it.

Delete an element or attribute. Deleting an element deletes all its child elements as well.

It is not possible to delete the root node.

y

Elements of the XML export configuration panel


294 Creating messages

Creating messages

Choose the

Annunciator configuration

command to create messages displayed in the messages panel of the data manager.

q

The data manager comes with predefined messages.

It is recommended to leave these predefined messages unchanged. Only create new messages, including new categories and levels, if necessary.

In this section

Annunciator configuration window (294)

Categories tab (295)

Message levels tab (296)

Message configuration tab (298)

u

Related topics

• Message section (79)

Annunciator configuration window

f

System > Configuration > Devices

> Annunciator configuration

Choose the


command. The


window is displayed. It consists of the following tabs:

•

Categories

tab

•

Message levels

tab

•

Message configuration

tab



295

Order of creating messages

To create messages, perform the following steps in this order (regardless of the order of the tabs in the


window):

1. Create message categories on the

Categories

tab:

Message categories and subcategories group messages by message source, i.e., the components and functions of the

cobas Synergy

solution.

2. Create message levels on the

Message levels

tab:

Message levels sort messages into different severity levels and define the required user action to messages.

3. Create messages on the


tab:

Messages are assigned to a category or subcategory, and to a message level. Messages need a message text and can have an optional description.

Categories tab

To create message categories and subcategories, choose the

Categories

tab:

A

B

A

New category w Categories tab

B

New subcategory



Message levels tab

To create message levels, choose the

Message levels

tab:

A

A

Severity level tree panel w

Message levels tab

To create a message level, do the following:

1. In the severity level tree panel, highlight the appropriate severity level (

Information messages

,

Warning messages

, or

Error messages

).

2. Choose the

Add

button.

3. In the

Level configuration


4. Choose the

Save

button.

q

You cannot delete message levels that are assigned to a message.

Level configuration group box

In the


group box, define the individual message levels.

Changes in the


group box affect all messages assigned to this level.

The check boxes in the


group box are ordered hierarchically:

Selecting the higher-level check box enables the lowerlevel check boxes.



297

Element

Message level

field

Description

When creating a message level, the next free numerical message level value is automatically allocated to the new message level.

You can change the numerical message level value to another free value.

Description

field Enter a description of the message level, e.g. consisting of severity and user reaction in short.

Annunciate message

check box Select to display assigned messages in the messages panel of the data manager.

Require acknowledgement of message

check box

Require user name entry

check box

Require password entry

check box

Limit to one annunciation per day

check box o

Select to require user acknowledgment of the assigned messages.

Select to require user name entry for user acknowledgment of the assigned messages.

Select to require user password entry for user acknowledgment of the assigned message.

Select to display any associated message once per day only (regardless of how many times the system raises the message).

o

Clear to display each associated message each time it is raised.

y Elements of the Level configuration group box



Message configuration tab

To create messages, choose the


tab:

A

A

Categories tree panel w

Message configuration tab

To create a message, do the following:

1. In the categories tree panel, highlight the previously created category or subcategory to which you want to create the message.

2. Choose the

Add

button.

3. In the



4. Choose the

Save

button.

Message configuration group box

In the


group box, define the individual messages.

Element

Level

drop-down list

Identifier

field

Verbose

field

Description

Choose a previously created message level to assign the message to it.

Enter the message text that is displayed in the

ID

column in the messages panel of the data manager.

Optionally, enter a description of the message.

y

Elements of the Message configuration group box


The Manager environment

Advanced configuration of data manager

Table of contents

299

17

In this chapter

17

The Manager environment of the data manager . . . . 301

Accessing the Manager environment . . . . . . . . . . 301

About the Manager environment . . . . . . . . . . . . . . 302

Menu overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 303

Setting system information codes . . . . . . . . . . . . . . . . 304

System information codes work area. . . . . . . . . . . 304

General Codes tab . . . . . . . . . . . . . . . . . . . . . . . . . . 305

Password Confirmation tab . . . . . . . . . . . . . . . . . . . 309

Language Settings tab (setting system language) 310

Security Configuration tab. . . . . . . . . . . . . . . . . . . . 310

Host Query tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 311

Managing software access . . . . . . . . . . . . . . . . . . . . . . 312

Security access configuration work area. . . . . . . . 313

General information tab. . . . . . . . . . . . . . . . . . . . . . 315

Menu restrictions tab. . . . . . . . . . . . . . . . . . . . . . . . 316

Test restrictions tab . . . . . . . . . . . . . . . . . . . . . . . . . 318

Database restrictions tab. . . . . . . . . . . . . . . . . . . . . 319

Language settings tab (setting user-specific language). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 321

Managing users on the data manager . . . . . . . . . 322

Locking tests, reports, and accept methods . . . . . . . . 324

User lock and distributor lock. . . . . . . . . . . . . . . . . 324

Database – Test locking work area . . . . . . . . . . . . 325

Database – Report Locking work area . . . . . . . . . 326

Database – Validate Locking work area . . . . . . . . 327

Entering laboratory details . . . . . . . . . . . . . . . . . . . . . . 328

Viewing log files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 329


300

Table of contents

View operator activity log work area . . . . . . . . . . . 329

Viewing program errors log files . . . . . . . . . . . . . . 330



301

The Manager environment of the data manager

Access the Configuration environment and the Manager environment, respectively, for advanced configuration of data manager.

In this chapter, you find how to use the Manager environment.

q

The menu paths given below at the beginning of each section are the absolute paths starting from the data manager.

In this section

Accessing the Manager environment (301)

About the Manager environment (302)

Menu overview (303)

u

Related topics


Accessing the Manager environment

1

r

To access the Manager environment

1


System > Manager

.

f

The Manager environment is displayed.


302 The Manager environment of the data manager

About the Manager environment

f


A

B

C

E

D

A

Menu

B

Quick access button to the

System information codes

work area

C

Quick access button to the

Security access configuration

work area w Manager environment

D

Logged in user

E

Navigation buttons

F

Active database

Navigation buttons

Returns to the data manager

F

Displays the Configuration environment u

About the Configuration environment (286)

Displays the User Assistance



303

Menu overview

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Translation

Information

Codes

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Laboratory details

Reports

Accept methods w

Overview of the Manager environment menu structure

Operator activity

Program error

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Main

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Access to commands depends on user rights.


304 Setting system information codes

Setting system information codes

To set functionalities and features determining system behavior of the data manager, choose the

Information

Codes

command.

NOTICE

Unexpected software behavior

When changing information code settings, restart the data manager for the new settings to take effect. The system warns you accordingly when saving the changes.

r Always restart the data manager after changing information code settings.

In this section

System information codes work area (304)

General Codes tab (305)

Password Confirmation tab (309)

Language Settings tab (setting system language) (310)

Security Configuration tab (310)

Host Query tab (311)

System information codes work area

f

System > Manager > System settings

> Information Codes

Choose the

Information Codes

command. The


work area is displayed. It consists of the following tabs:

•

General Codes

tab

•

Password Confirmation

tab

•

Language Settings

tab

•

Security Configuration

tab

•

Host Query

tab

On each tab, choose from the pre-defined drop-down lists.


General Codes tab


305

To determine general system behavior of the data manager, choose the

General Codes

tab.

w

General Codes tab



Element

Check lot expiry date on sign-on

drop-down list

Automatically generate aliquot plate (if none exists)

list

drop-down

Allow re-reading / recalculation of plates

list

drop-down

Activity log – sensitivity

down list

dropy

Elements of the General Codes tab

Description

Choose how the data manager indicates that test lots or kit lots have expired: o

Yes

The data manager checks lot expiry dates at logon. The data manager displays the lot numbers of any lots that expire on that day. The lots in question can be used or can be removed.

o

No

(default value)

The data manager does not check for lot expiry dates at logon. If a lot has expired, the data manager warns when a plate is generated.

o

Server and clients belonging to the

cobas Synergy

solution

If you choose a listed computer, the data manager checks for and reports expired lots at logon on that computer. This means, you always use the same computer on the network to monitor and report lot expiry dates.

Choose what happens if the data manager does not recognize a plate ID as matching an unread aliquot plate: o

Yes

If you read an aliquot plate that has not been predefined, you can manually enter the new aliquot plate details.

o

No

You cannot read aliquot plates that have not been predefined, or prepared and imported from a pre-analytical system. I.e. if the aliquot plate is not on the unread aliquot plate list, then it cannot be processed. You must pre-enter the aliquot plate details using the

Enter Plate Details

command.

o

Prompt

(default value)

If you read an aliquot plate that has not been predefined, the data manager prompts you to enter the plate details manually.

Choose if an aliquot plate can be reread and results recalculated: o

Yes

Any aliquot plate can be reread and recalculated regardless of its previous status.

o

No

(default value)

An aliquot plate can be read only once. Even if the aliquot plate is rejected without saving the results to the database, no further reading of that aliquot plate is allowed.

o

Abandoned only

Aliquot plates can be reread, if their previous results have not been saved. For example, the aliquot plate was read, but the results were rejected. Aliquot plates that have been read and had their results saved cannot be reprocessed.

o

Failed only

Only aliquot plates that fail the control criteria can be reread. Once an aliquot plate has successfully passed the control criteria and the results were saved, no further reading of that aliquot plate is allowed. User-rejected aliquot plates cannot be reprocessed.

The data manager can log all activities in a user activity log. The software divides all activities into categories ranging from Routine to Critical. Using these categories, choose how much information is stored within the activity log: o

Ignore None

(default value)

All user activity is logged.

o

Ignore Routine

User activities classified as Routine are ignored. Activities classified as Minor, Major, or Critical are logged.

o

Ignore Minor, Routine

User activities classified as Routine or Minor are ignored. Activities classified as

Major or Critical are logged.

o

Ignore Major, Minor, Routine

User activities classified as Routine, Minor, or Major are ignored. Only activity classified as Critical is logged.

o

Ignore All

All user activities are ignored. No event data is logged in the activity log. This option effectively switches off the activity log.

u

Viewing log files (329)



307

Element Description

Include laboratory details on all fixed printouts

drop-down list

Include database name on fixed printouts and system menus

drop-down list

Choose to include laboratory details on all fixed-format printouts (e.g. the activity log printout): o

No

No laboratory details are included.

o

Name

Just the laboratory name is included.

o

Name and Address

(default value)

The laboratory name and address is included.

To enter the laboratory details, choose

Other > Laboratory details

in the Manager environment.

u

Entering laboratory details (328)

Choose to include the name of the active database on all fixed-format printouts, in the

Configuration environment, and the Manager environment: o

No

No database name is included.

o

Not Default

The name of the default database is not included. The name of any other database is included.

o

Always

(default value)

The database name is always included.

To set individual database access, choose

System settings > Security access

in the

Manager environment.

u

Database restrictions tab (319)

Unread plate list

drop-down list Set access to the unread aliquot plate list when reading new aliquot plates on the system: o

Yes

(default value)

The software displays the unread aliquot plate list. To read an aliquot plate, choose an aliquot plate from the unread aliquot plate list. You do not have to enter the aliquot plate name.

o

No

The software does not display the unread aliquot plate list. To read an aliquot plate you must enter the aliquot plate number, either using the keyboard or the barcode reader.

Assign default worklist profile

(i.e., first defined test group)

field

Use of this feature has been deprecated. y




Element

Double-blind entry of manually entered results

drop-down list

Prevent inadvertent testing

down list

Allow duplicate orders

down list

drop-

dropy


Description

Choose to confirm sample ID entry and the results entered manually for samples via

Main > Enter > Manual Details > Sample Result Entry

: o

No

(default value)

Manually entered samples are available within the system when they have been entered for the first time. Confirmation of the result is not required.

o

Yes – On Sample Number Entry

Manually entered samples must be entered twice. The software displays the

Confirm

Sample Number

dialog box to enter the sample ID again.

o

Yes – On Save to Database

Manually entered samples are not available within the system until a second identical result has been entered for the samples to confirm the first result.

o

Yes – On Sample Number Entry and on Save

Manually entered samples must be entered twice. The software displays the

Confirm

Sample Number

dialog box to enter the sample ID again. Additionally, the sample

IDs are not available within the system until a second identical result has been entered for the samples to confirm the first result.

Choose if sample IDs must be on a worklist before the results are saved to the database: o

No

(default value)

Samples not on the worklist are saved to the sample history for the test for which the aliquot plate was generated.

Samples on the worklist are saved to the sample history for the test for which the aliquot plate was generated.

o

Yes: Worklist entry required.

Samples not on the worklist are not saved to the sample history, but an entry is made in the sample action log.

Samples on the worklist are saved to the sample history for the test for which the aliquot plate was generated.

Choose if duplicate orders are assigned / imported to a worklist: o

Yes

(default value)

Duplicate orders are allowed on the worklist.

o

No

Duplicate orders are not allowed on the worklist.

o

Prompt

You are prompted to allow duplicate orders on the worklist.

The

Prompt

option defaults to

No

if you are using LIS import to create a worklist.



309

Password Confirmation tab

To improve security within the data manager, you can set up the software to prompt for the password before an activity. On the

Password Confirmation

tab, choose the activities that use this function.

A

A

Activity tree panel w

Password Confirmation tab

The check boxes in the activity tree panel indicate the password-required status.

To change the status, double-click the option in the activity tree panel and save the changes.

q

In some areas of the software, password confirmation is a mandatory function that cannot be switched off. The check box indicates these areas.



Language Settings tab (setting system language)

On the

Language Settings

tab, Roche Service sets system language during system installation.

NOTICE

Compromised user interface

Changing the system language setting may compromise the user interface terms.

r

Do not change pre-installed system language setting.

Security Configuration tab

To improve security within the data manager, choose the

Security Configuration

tab to define requirements for passwords, for example minimum password length or required characters.

w

Security Configuration tab


Host Query tab


311

The host query mode for worklists allows you to create order files for all samples and all tests, or for individual samples and all tests. To enable host query mode for worklists, choose the

Host Query

tab.

w

Host Query tab q

When you have enabled the host query mode for worklists and defined the folder location, these settings apply to all databases created on the system.


312 Managing software access

Managing software access

Choose the

Security access

command to do the following:

• Set up new users for the data manager along with their passwords and access rights.

• Manage existing users of the data manager.

!

CAUTION

Incorrect results

User setup may influence how the data manager handles/saves results.

r

Make sure to set up users correctly.

NOTICE

Unauthorized software access

User setup determines user access to menus, tests, and databases.

r

Make sure to restrict user access accordingly.

In this section

Security access configuration work area (313)

General information tab (315)

Menu restrictions tab (316)

Test restrictions tab (318)


Language settings tab (setting user-specific language) (321)




313

Security access configuration work area

f

System > Manager > System settings > Security access

Choose the

Security access

command and enter your password. The


work area is displayed.

q

Access to the


work area depends on user rights.

A

B

A

User list panel w

Security access configuration work area

B

Tabs panel

The


work area consists of the following panels:

• The user list panel on the left, displaying a list of all existing users.

• The tabs panel on the right, displaying the following tabs:

-

General information

tab

-

Menu restrictions

tab

-

Test restrictions

tab

-

Database restrictions

tab

-

Language settings

tab



Basic user management

In the


work area, you can perform user management:

• To create a user, choose the

New

button and enter the required data on the tabs in the tabs panel.

• To edit a user, choose the user from the user list. On the tabs, make the required changes.

• To assign the same access rights to another user (to simplify data entry), do the following:

1) To copy access rights from a particular user, choose the user from the user list and choose the

Copy

button.

2) To assign access rights to another user, choose the user from the user list and choose the

Paste

button.

• To delete a user, choose a user from the user list and choose the

Delete

button.

The deleted user cannot access the software anymore, but all previously saved records and actions of that user remain.

q

Changes on the tabs of the tabs panel only apply to the user chosen in the user list.



315

General information tab

To enter basic user data, choose the


tab.

w

General information tab

Element

First name

field

Last name

field

Login name

field

Description

Enter the user’s first name.

Enter the user’s last name.

o

The data manager enters a default logon name:

The first 6 letters of the last name plus the first letter of the first name (all in lower case) o

Alternatively, delete the default logon name and enter a different logon name for the user.

Password expiry

drop-down list Choose if the user’s password expires automatically: o

NONE

The password never expires.

o

[Number]

The password expires after the chosen number of days.

Once a password has expired, the user cannot access the software using the expired password. The software automatically prompts for a new password, which must be different from the last password.

y Elements of the General information tab



Element

Password

button

Security level

drop-down list

Description

To enter the password for the user, choose the

Password

button.

The password must follow the password restrictions defined on the

Security

Configuration

tab of the


work area.

u

Security Configuration tab (310)

Upon software installation, each command belongs to a pre-defined security level, based on typical user roles in a laboratory. To set menu access for the user, assign the user to the appropriate security level: o

Operator

o

Technical Validator

o

Laboratory Supervisor

o

Field Service Engineer

(for Roche Service only)

A security level enables access to all commands of that level as well as to all commands of lower security level.

To view the access rights associated with a security level and to adapt them manually for the individual user, if necessary, choose the


tab.

u


Comments

field

Note: When creating a user, it is possible not to choose a security level. In this case, the new user has access to all commands.

Enter a free text comment, if necessary.

y Elements of the General information tab

Menu restrictions tab

Choose the


tab to do the following:

• View menu access rights associated with a predefined security level (by viewing a user assigned to this security level).

• Manually adapt menu access rights for a particular user.


A

B


317

A

Commands tree w Menu restrictions tab

B Force Continue

option

To change user access rights, do the following:

• To change access right to a command, double-click the corresponding option in the commands tree.

• To allow access to all commands, choose the

Select

All

button.

• To restrict access to all commands, choose the

Select

None

button.

q

A red background shown for any command indicates that the access rights for this command are fixed and cannot be changed.

NOTICE

Incorrect results when using the Force Continue command

Access to the

Force Continue

command allows the user to override test failures and force the aliquot plate through to completion, which may lead to incorrect results.

r

Use the

Force Continue

command in special cases only, for example during test development.

r

Restrict access to the

Force Continue

command for routine data processing and operation.



Test restrictions tab

A B C

To set menu access rights on a test basis, choose the


tab.

You can limit access to just the tests the user is authorized to use, even though the user has general access to that command. Or you can prevent manual editing of tests, for example of ‘sensitive’ tests such as

HIV.

NOTICE

Unauthorized test access

The tests listed on the


tab are based on the currently active database. Therefore, any settings within the


tab are specific to that database, which may lead to unauthorized test access when changing the database.

r

Always reassign test restrictions when changing the database (e.g., after an update of the data manager).

A Enable individual test restrictions

check box

B

Command option w

Test restrictions tab

C

D

D

Test option

Allow real-time sample result editing


drop-down list


319

To set user access rights based on tests, do the following:

1. Select the

Enable individual test restrictions

check box.

2. Expand the command entries to show the tests currently available in the data manager.

3. Double-click a test option to change access to this command for this test.

4. Determine if the user is allowed to edit the results of individual wells within agglutination (blood grouping / hemagglutination) tests before saving the result.

Choose the corresponding option from the

Allow real-time sample result editing

drop-down list:

-

No

No results can be edited.

-

Equivocals Only

Only invalid results can be edited.

-

Yes

Any result can be edited.

Database restrictions tab

You can use multiple results databases in the data manager. For example, a routine testing database, a training database, and a test validation database.

To set/restrict access rights to databases, choose the


tab.

NOTICE

Unauthorized database access

A new user has access to all databases, which may lead to unauthorized database access.

All existing users have access to newly created databases, which may lead to unauthorized database access.

r

Make sure to set/restrict database access when creating users and when creating databases.



A B

A

Databases table w

Database restrictions tab

B Login Database

drop-down list

From the

Login Database

drop-down list, choose the database the user accesses at logon:

•

<DEFAULT>

The user accesses the default database.

Roche Service configures the default database during system installation.

•

<SELECT>

The user can select from a list containing all databases for which the user has access rights.

• Database name

The user accesses the specified database.

In the databases table, double-click a database to change access right.



321

Language settings tab (setting user-specific language)

On the


tab, choose the

[System

Default]

option to set the user-specific language to the system language.

NOTICE

Compromised user interface

User-specific language overrides the pre-installed system language, which may compromise the user interface terms. r

When setting up a new user, make sure to choose the

[System Default]

option on the


tab to default to system language.

w

Language settings tab



Managing users on the data manager

You can create users on the data manager and assign them to a security level.

Refer to the following sections for a detailed description of the tabs in the


work area: u

Security access configuration work area (313)

u

General information tab (315)

u


u

Test restrictions tab (318)

u


u

Language settings tab (setting user-specific language) (321)

j m

Access to the


work area depends on user rights.

3

r

To create a user on the data manager

1



> System settings > Security access

.

2

In the

Security Confirmation

dialog box, enter your user name and password.

3

On the


tab, choose the

New

button.

f

A new user “Noname” is added to the user list panel on the left.

4

Enter the following fields:

•

First name

•

Last name

•

Login name

Either keep the default login name or enter a different login name.

5

Choose the

Password

button. Enter the password twice.

I

The password must adhere to the requirements as defined in

System > Manager > System settings > Information codes

.

6

To set the password to expire automatically, from the

Password expiry

drop-down list, choose the corresponding option.



323

9

10

7

Set menu access rights:

• To set access rights globally, from the

Security level

drop-down list, choose a security level.

• Alternatively, to set access rights individually, on the


tab, select/clear the corresponding check boxes.

8

Optionally, enter a comment in the

Comments

field.

9

NOTICE Risk of compromised user interface.

When setting up a new user, make sure to choose the

[System Default]

option on the


tab.

9 Optionally, adjust the settings on the


tab, the


tab, the


tab, and the


tab.

10

On the


tab, choose the Save button.


324 Locking tests, reports, and accept methods

Locking tests, reports, and accept methods

To display the locking work areas, choose

Database

> Locking

. In the locking work areas, you can prevent changes in tests, reports, and accept methods by locking them.

In this section

User lock and distributor lock (324)

Database – Test locking work area (325)

Database – Report Locking work area (326)

Database – Validate Locking work area (327)

User lock and distributor lock

When locking a test, report, or accept method, choose between user lock and distributor lock, depending on the preferred security level:

• User lock:

Apply/remove a user lock in the following ways:

- Double-click a test, report, or method, and then choose the

Apply

button.

- Right-click a test, report, or method. On the shortcut menu, choose the

Lock

command or the

Unlock

command.

Each user with access to the locking work areas can remove a user lock, i.e., make tests, reports, and methods editable again.

• Distributor lock:

To apply a distributor lock to a test, report, or method, right-click it. On the shortcut menus, choose the

Distributor Lock

command. The software prompts you to enter a locking password.

Only users with access to the locking work areas and knowledge of the locking password can remove a distributor lock.

A corresponding symbol indicates the locking status in the locking work areas.



325

Database – Test locking work area

f

System > Manager > Database > Locking

> Tests

In the

Database – Test locking

work area, protect tests from accidental or unauthorized editing.

A

A

Filter options w

Database – Test locking work area

Apply a user lock or a distributor lock to the test you want to lock.

u



326 Locking tests, reports, and accept methods

Database – Report Locking work area

f


> Reports

In the

Database – Report Locking

work area, protect reports from accidental or unauthorized editing.

A

A

Filter options w

Database – Report Locking work area

Apply a user lock or a distributor lock to the reports you want to lock.

u




327

Database – Validate Locking work area

f


> Accept methods

In the

Database – Validate Locking

work area, protect accept methods from accidental or unauthorized editing.

A

A

Filter options w

Database – Validate Locking work area

Apply a user lock or a distributor lock to the accept method you want to lock.

u



328 Entering laboratory details

Entering laboratory details

f

System > Manager > Other > Laboratory details

Laboratory details dialog box

In the

Laboratory details

dialog box, enter your laboratory name, address, and post or zip code.

In the


work area, set the corresponding information code to include the name, or name and address of your laboratory on all fixed-format printouts.

u




329

Viewing log files

The data manager keeps log files of user activities (if configured) and program errors.

To configure the data manager to keep a log of all user activities within the software, and to set the level of information keeping, choose

System settings

> Information codes > Activity log – sensitivity

. u


In this section

View operator activity log work area (329)

Viewing program errors log files (330)

View operator activity log work area

f

System > Manager > View log file > Operator activity

In the

View operator activity log

work area, you can view the contents of the user activities log.

The activity log is displayed as a table.

A

B

A Search Parameters

group box w

View operator activity log work area

B

Activity log table


330 Viewing log files

You can set search filters in the

Search parameters

group box. By default, when choosing the

Search

button, all logged user activities are displayed.

To print the activity log and to save it as PDF, choose the

Print

button. The printer selection and configuration is controlled through your local Windows setup.

Viewing program errors log files

f

System > Manager > View log file > Program error

If a system or program error occurs during routine operation of the data manager, the software writes the error to a log file called

Errors.log

. The log file is stored in the

Executable

folder.

w

Program errors log file

To open the

Error.log

file using the internal

ViewPad

program, choose

View log file > Program error

.

Alternatively, go to the

Executable

folder and open the

Error.log

file with an external text editor.


Appendix

18 Key terms.................................................................................................................333

19 Glossary ...................................................................................................................337

Index..........................................................................................................................339


Key terms

Table of contents

333

18

In this chapter

18

Comparison of key terms. . . . . . . . . . . . . . . . . . . . . . . . 335


334

Table of contents


Key terms

335

Comparison of key terms

Terms differing between the individual components of the

cobas Synergy

solution are indicated in the respective glossary entries.

u

Components of the cobas Synergy solution (46)

u

Glossary (337)


336 Comparison of key terms


Glossary

337

5-position rack carrier - server dongle

Glossary

Terms differing between the individual components of the

cobas Synergy

solution are indicated in the respective glossary entries below.

5-position rack carrier

Carrier with 4 positions that is used to load 5-position racks onto the instrument.

The 5-position rack is referred to as the

Hitachi fiveslot rack

in some pre-analytical systems.

aliquot plate carrier

Carrier with 5 positions that is used to load aliquot plates onto the instrument.

barcode reader

A device which reads barcodes.

baseline step

Decrease in fluorescence intensity caused by a change in the PCR annealing/extension temperature during data collection. It is caused by the temperature dependence of the dye’s fluorescence.

The magnitude of the step is dye dependent and constant for a given temperature change.

carrier

Oblong rack that is placed on the instrument and is used for loading and carrying containers, racks, or supplies.

carryover

Contamination of a test by reagents or a sample of a previous test.

cutoff value

For qualitative test, a value which indicates clinically significant amount or presence of an analyte in the sample. Below this value a qualitative test result is determined to be negative and above positive.

data manager

Component of cobas Synergy software that is run on a separate server accessed via a workstation. It is used to create and manage pooling runs and validate and release results.

deepwell plate (DWP)

Flat plate with multiple square or round wells with larger capacity than microwell plates used as a reservoir in analytical research and clinical diagnostic testing laboratories.

The format ranges from 8 to 384 wells which are arranged in a 2:3 rectangular matrix. Wells can be alphanumerically labeled to make sample identification easy.

dilution

Process of adding a material, usually a liquid or gas, to another material or substance for purposes of decreasing the concentration of the former.

eluate

Solution consisting of elution buffer with

DNA/RNA separated from the magnetic glass particles.

19 environmental conditions

Characteristics of environment such as temperature, humidity, lighting, altitude which may influence the operation of electronic equipment.

laboratory information system (LIS)

Computer system that supports the automation of laboratory management.

maintenance action

Action which needs to be carried out to keep laboratory instruments in good condition. It can either refer to a single action or to a procedure consisting of several steps.

periodic maintenance

Maintenance actions which need to be performed on regular intervals.

pool carrier

Carrier with 4 positions that is used to load 5-position racks with pool tubes onto the instrument.

pool tube

Tube used for the creation of pools of sample. Referred to as

secondary tube

in

cobas

®

6800/8800 Systems.

pooling instrument manager

Component of cobas

Synergy software that is run on the control unit of

Microlab® STAR IVD. It is used to perform pooling runs on the pooling instrument.

primary pool

Pool initially created in the pooling workflow.

primer

Single-stranded nucleic acid that can initiate replication of a template.

quantitation standard (QS)

Standard used in quantitative tests to determine the copy number of the unknown target nucleic acid.

Roche Service representative

Trained representative of Roche Diagnostics who may install instruments and/or perform preventive maintenance and/or service activities.

sample rack

Rack used to hold sample tubes.

secondary pool

Pool of any pool size triggered by an invalid or reactive result of a pool.

server dongle

Dongle necessary to operate the server of cobas Synergy software.


338 Glossary

threshold cycle (Ct) - workstation dongle

threshold cycle (Ct)

Fractional cycle number where sample fluorescence exceeds a predetermined threshold (the Assigned Fluorescence Level (AFL)). It indicates the beginning of an exponential signal growth phase. Therefore, a higher value means a lower titer.

tip rack carrier

Carrier with 5 positions for tip racks.

Total Aspiration Dispensing Monitoring (TADM)

Feature which monitors the pressure curve during aspiration and dispensing. As result, clot, leakage, and foam can be detected.

trolley

Table on wheels on which an instrument is installed.

uninterruptible power supply (UPS)

Device with a battery that allows limited continued operation of an instrument or other device during a power outage.

USB flash drive

External storage device with a flash memory chip.

workstation

External PC that is part of cobas

Synergy software necessary to run the data manager.

workstation dongle

Dongle necessary to operate the workstation of cobas Synergy software.


Index

339

Index

Numerics

5-position racks, 67

– stabilizers, 67

A

Accept methods

– locking, 324

Accessing cabinets during run, 34

Addresses, 6

Alarm report, 176, 235

Alarms, 233

– resolving, 233

Aliquot plate carriers, 69

Aliquot plates, 73

– barcodes, 73

Archive

– accessing (data manager), 280

Archiving (data manager), 279

Autoload tray, 61

Autoload unit, 60

Autoloader

– moving manually, 229

– components, 46

– run types, 49

Components

– cobas Synergy solution, 46

Configuration environment, 285

– accessing, 285

– menu structure, 287

– software structure, 286

Configuration order (data manager), 259

Consumables, 70

– aliquot plates, 73

– pipette tips, 72

– tubes, 70

Contact, 6

Control unit

– restarting, 228

– switching on, 121

Conventions used in this publication

– abbreviations, 10

– product names, 9

– symbols, 9

Copyright, 3

Cover, safety information, 28

Covers, 53

Creating reports, 152, 155, 158

B

D

B19 high titer workflow, 171

– complete unresolved, 154

– force unresolved result, 154

Backup (data manager), 276

Barcode reader

– cleaning window, 230

Barcodes, 71, 73

C

Carriers, 65

– aliquot plate carriers, 69

– loading, 127

– samples, 66

– tip rack carriers, 69

– unloading, 127

Change requests, 152

Circuit breakers and fuses, 33

Cleaning

– autoload protecting ribbon, 198

– instrument covers, 198

– laser scanner window, 198

– tip eject plate, 198

Client-server architecture, 48

cobas omni tubes, 71

cobas Synergy solution

– client-server architecture, 48

data manager

– accessing archive, 280

– archiving, 279

– backup, 276

– Configuration environment, 285

– configuration order, 259

– configuring, 257, 285, 301

– connecting instruments, 270

– creating messages, 294

– creating problem reports, 234

– creating report, 178

– exclusion lists, 273

– general codes, 305

– general settings, 273

– global information area, 78

– handling report, 179

– host query, 311

– IDT runs configuration, 268

– instrument titer cutoff, 274

– laboratory details, 328

– languages, 310

– LIS export, 288

– locking, 324

– log files, 329

– Manager environment, 301

– managing users, 312

– map files, 291


340 Index

– message panel, 79

– navigating, 85

– panels, 85

– password cnfirmation, 309

– primary runs configuration, 266

– processing results, 275

– reports, 174

– resolving alarms, 233

– security configuration, 310


– system information codes, 304

– targets configuration, 260

– tests configuration, 263

– troubleshooting, 233

– User Assistance, 93

– work area, 84

Data security, 32

Dimensions, 110

Disposal

– of waste, 27

Donor result report, 146, 157, 176

Donor summary report, 177

E

Edition notice, 2

Environmental conditions, 109

Errors

– hardware, 219

– identify carrier, 221

– identify consumables, 224

– load carrier, 221

– pipetting, 227

– reading barcodes, 224, 230

– tip eject, 226

– tip pickup, 226

– unload carrier, 223

Evaporation of samples, 30

Exclusion lists, 106

– file names, 106

– location, 106, 273

F

Fatigue due to long hours of operation, 31

Feedback, 4

Forcing unresolved results, 154

– invalid HAV result, 171

Fuses and circuit breakers, 33

I

H

Host query, 311

Identify carrier errors, 221

Identify consumable errors, 224

IDT, 99

IDT runs

– editing, 268

Improper loading, 34

Individual Donor Testing (IDT), 99

Initial reactive pools report, 168, 177

Instrument approvals, 4

Instrument deck, 56

Instrument titer cutoff, 274

Instruments

– adding, 270

– connecting, 270

Intended use, 9

Interference during run, 34

Invalid DPX pool results report, 146, 154, 156, 176

Invalid HAV results, 171

Invalid pools, 165

Invalid test results report, 177

L

Laboratory details, 328

LED bar, 55

LIS export configuration, 288

– changing, 289

– creating, 289

– deleting, 289

– map files, 291

Load carrier errors, 221

Locking

– distributor lock, 324

– user lock, 324

Locking the control unit, 124

Locking the workstation, 124

Log files, 329

– operator activity, 329

– program errors, 330

Logging off, 124

Logging on

– data manager, 123

– pooling instrument manager, 122

G




M

Maintenance

– daily, 191

Manager environment, 301

– accessing, 301

– menu structure, 303


Index

341


Manual ID entry, 224

Manual ordering, 135

Map files, 291

Masking, 154

Mechanical safety, 28

Menu structure

– Configuration environment, 287

– Manager environment, 303

Message panel (data manager), 79

Messages

– categories, 295

– configuring, 298

– creating, 294, 298

– creating order, 295

– levels, 296

Minimum pool size, 274

N

New in version, 14

P

Panels (data manager), 85

Personal protective equipment, 21

Pipette tips, 72

Pipetting arm, 62

Pipetting channels, 34

Pipetting errors, 227

Plates

– aliquot plates, 73

Pool size

– minimum, 274

Pool tubes, 71

– cobas omni tubes, 71

Pooler performance export report, 177

Pooler performance report, 177

Pooling instrument

– dimensions, 110

– environmental conditions, 109

– power rating, 109

– space, 110

– specifications, 109

– weight, 110

pooling instrument manager

– changing password, 254

– configuring, 249

– creating users, 252

– deleting users, 253

– global information area, 89

– managing users, 249

– navigating, 91


– User assistance, 94

– user groups, 251

– work area, 90


Pooling run status report, 137, 146, 155, 156, 165, 168,

176

Pools

– invalid, 165

Power rating, 109

PP24, 99, 100

PP6, 99, 100

PP96, 99, 100

Pre-analytical systems, 135

– interface, 135

Primary pools, 99, 100

Primary runs

– adding, 266

– editing, 266

Problem report, 234

R

Rack-based ordering, 135

Racks, 65, 67

– stabilizers, 67

Reactive pools, 101

Rejecting pooling runs, 152

Repeat pools, 99, 103

Report

– Alarm, 176, 235

– creating, 178

– Donor result, 146, 157, 176

– Donor summary, 177

– handling, 179

– Initial reactive pools, 168, 177

– Invalid DPX pool results, 146, 154, 156, 176

– Invalid test results report, 177

– Pooler performance export report, 177

– Pooler performance report, 177

– Pooling run status, 137, 146, 155, 156, 165, 168, 176

– Problem, 234

– Results to pooling run, 146, 168

– Results to pooling run ID, 152, 176

– Sample audit, 146, 176

– Samples to reload, 136, 137, 146, 152, 165, 168, 176

– Testing summary report, 177

– types, 174

– Where is my sample report, 176

Reports

– locking, 324

Restrictions

– databases, 319

– menus, 316

– tests, 318

Results

– automatic processing, 275

Results to pooling run ID report, 146, 152, 168, 176

Revision history, 2

Run types, 49

342 Index

S

Safety

– data security, 32

Safety classification, 20

Safety guards, 61

Sample audit report, 146, 176

Sample carriers, 66

Sample tubes, 70

– barcodes, 71

Samples

– finding, 176

– searching, 173

Samples to reload report, 136, 137, 146, 152, 165, 168,

176

Screenshot disclaimer, 3

Searching

– samples, 173

Secondary pools, 99, 101

Software structure



Solid waste, 63

– bag, 63

– container, 64

– emptying, 133

SP6, 99, 102

Space requirements, 110

Spillage, safety precaution, 35

Stabilizers, 67

Starting up, 121


– pooling instrument, 121


Status light, 65

Stop hooks, 61

– broken, 232

System information codes, 304

– general codes, 305

– host query, 311

– languages, 310

– password confirmation, 309

– security configuration, 310

System restart, 185

Tip rack carriers, 69

Tip racks, 72

Titer cutoff, 274

Trademarks, 4

Troubleshooting

– Alarm reports, 235

– autoloader, 229

– barcode reader, 230

– control unit, 228


– hardware, 219

– identify carrier errors, 221

– identify consumable errors, 224

– invalid HAV results, 171

– load carrier errors, 221

– pipetting errors, 227

– Problem report, 234

– resolving alarms, 233

– stop hooks, 232

– tip eject errors, 226

– tip pickup errors, 226

– unload carrier errors, 223

Tubes, 70

– pool tubes, 71

– sample tubes, 70

U

Unload carrier errors, 223

User Assistance, 93

– browser, 94

– navigation history, 96

– offline, 95

Users

– changing password (pooling instrument manager),

254

– creating (pooling instrument manager), 252

– database restrictions (data manager), 319

– deleting (pooling instrument manager), 253

– groups (pooling instrument manager), 251

– information (data manager), 315

– lanuguages (data manager), 321

– managing (data manager), 312

– managing (pooling instrument manager), 249

– menu restrictions (data manager), 316

– security levels (data manager), 315

– test restrictions (data manager), 318

T

Targets

– adding, 260

– editing, 260

Teaching needles, 62

Testing summary report, 177

Tests

– adding, 263

– editing, 263

– locking, 324

Tip eject errors, 226

Tip pickup errors, 226

V

Verification, 200

W

Warranty, 3

Waste, 26

Waste bag, 63


Waste chute, 64

Weight, 110

Where is my sample report, 176

Work area



Index

343


344 Index


Roche cobas Synergy Software Operators Manual

cobas Synergy software

For use with

cobas

®

6800/8800 Systems (software version 1.2.13) and

Microlab

®

STAR IVD

User Assistance Version 3.0

Software version 1.2

Publication information

Edition notice

Where to find information

Training

Disclaimer

Screenshots

Warranty

Copyright

General attention

License information

Open Source and Commercial Software

Trademarks

Feedback

Approvals

Contact addresses

Table of contents

Intended use

Symbols and abbreviations

Product names

Symbols used in the publication

Symbols used on product

Abbreviations

What is new in publication version 3.0

Analytic system

Intended use

Pool details

Resending test results

Workflows in case of high B19 titer

Error messages

Configuring targets

Configuring tests

Screenshots updated

What is new in publication version 2.0

Analytic system

Sorting and filtering of tables

User management

Exclusion lists

Pooling and aliquot workflows

Quick references

Masking a test order

Searching samples

Workflows in case of high B19 titer

New cobas Synergy reports

Handling sample barcode errors

Data manager messages

Backing up and archiving databases

User Assistance

General improvements

What is new in publication version 1.1

cobas Synergy reports added

Repeat testing on the analytic system

Workflows in case of high B19 titer

Minimum pool size

Updates in Configuration part

Aurora reports

Safety

General safety information

Introduction

General attention

Safety classifications

Safety alert

Warning...

Caution...

Notice...

Safety precautions

To avoid serious or fatal injury, read and comply with the following safety precautions.

In this section

Operator qualification

Insufficient knowledge and skills